Alkali Therapy in Chronic Kidney Disease: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Alkali Therapy in Chronic Kidney Disease (NCT01452412), a randomized phase 2, phase 3 study. The primary outcome is Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times.

2. Clinical Question

The trial also posted results for hand-grip strength, estimated GFR, and the physical-function domain of quality of life. These outcomes broaden the question beyond performance on the sit-to-stand task, but the registry record does not report a single combined outcome or an overall treatment-effect estimate across measures.

The stated rationale is that acid build-up associated with kidney disease may affect muscles, bones, glucose metabolism, and kidneys. That rationale explains the range of outcomes under study; it does not establish that a particular result occurred. The clinical question addressed by the primary endpoint is specifically about the time needed to perform the repeated movement task, not about every possible effect of alkali therapy or the underlying disease.

3. Trial Design

The registry describes a randomized, placebo-controlled, parallel-group clinical trial with quadruple masking. It lists phase 2 and phase 3 and a total enrollment of 149. The trial status is completed. The listed start is 2011-10 and the primary completion is 2016-08. Albert Einstein College of Medicine is listed as sponsor.

One group received sodium bicarbonate, described as 0.4 mEq/kg/day of ideal body weight taken once a day. The comparison group received placebo with dosage and frequency equivalent to sodium bicarbonate. The parallel design means participants were assigned to one group rather than crossing between both treatments in the reported design. Random assignment is intended, in general, to support comparisons between groups by reducing systematic differences at assignment; it does not guarantee that the groups will be identical in every respect.

The term quadruple masking indicates a masking category in the registry. Which specific people or roles were masked, and the procedures used to maintain masking, are not reported in the registry record. Further details about allocation procedures, concealment, eligibility criteria, recruitment, and adherence are also not reported in the registry record.

The posted primary results list 74 participants in the sodium bicarbonate group and 75 in the placebo group. The arm summaries report means and standard deviations for the primary measure at 2 year. The registry lists three secondary outcomes, also with 2 year measurements. These group summaries are useful for describing the recorded results, but they do not provide details about participant flow, the number with missing measurements, or the analysis population used for each result.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times, measured over 2 year.

The primary endpoint is the time taken to complete sit to stand to sit 10 times, recorded in seconds. It is a repeated movement task: a participant performs the sit-to-stand-to-sit sequence ten times, and the elapsed time is measured. The registry describes comparing the measure between groups at 2 year.

Time is a direct, continuous measure of task performance. In general, a shorter recorded time means the sequence was completed more quickly, while a longer time means it took longer. That interpretation describes the scale itself; it does not by itself establish whether a group difference is clinically important. The registry record does not report a threshold for a meaningful change, a minimum important difference, or a detailed measurement protocol such as equipment, assessor procedures, or repeat testing.

A repeated movement task can be relevant to physical function because it records performance of a practical movement rather than relying only on a report of perceived function. At the same time, the result is limited to the task as measured. It does not directly measure all muscle function, mobility, independence, or quality of life. The registry also does not report how baseline task performance was incorporated in the analysis, or whether the posted values represent change from baseline or measurements at the stated time point.

The reported comparison is a difference in group means, so it describes the average recorded time in each group. Individual participants may have had faster or slower times than their group average. A mean comparison therefore does not show the full distribution of performance or how many participants experienced a particular change.

7. Results Posted in the Registry

• Sodium Bicarbonate: mean 23.80 versus 22.90 on control; difference 0.90 (95% CI -1.08 to 2.88), standardized effect d = 0.15; z-test p = 0.372.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Hand-grip Strength

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Sodium Bicarbonate: mean 27.30 versus 24.90 on control; difference 2.40 (95% CI -0.81 to 5.61), standardized effect d = 0.24; z-test p = 0.143.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Sodium Bicarbonate and the control. The interval gives the range of effects that remain compatible with the data.

Estimated GFR

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Sodium Bicarbonate: mean 38.50 versus 36.30 on control; difference 2.20 (95% CI -3.00 to 7.40), standardized effect d = 0.14; z-test p = 0.407.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Sodium Bicarbonate and the control. The interval gives the range of effects that remain compatible with the data.

Quality of Life - Physical Function Domain

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Sodium Bicarbonate: mean 40.00 versus 43.00 on control; difference -3.00 (95% CI -6.70 to 0.70), standardized effect d = -0.26; z-test p = 0.112.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Sodium Bicarbonate and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists three secondary outcomes at 2 year: hand-grip strength, estimated GFR, and the physical-function domain of quality of life. Across them, the direction of the recalculated mean differences is not uniform: two estimates are higher in the sodium bicarbonate group and one is lower. Their confidence intervals include zero, so the posted summaries do not sharply distinguish the group differences from no difference.

This mixed pattern does not provide a consistent secondary signal that independently clarifies the primary result. The outcomes measure different constructs, use different scales, and have different levels of variability. Their numerical directions should not be treated as if they were interchangeable or combined into a single overall measure. The registry record does not report a composite secondary outcome or a joint analysis across these measures.

Secondary outcomes can add context by showing whether results on related or complementary measures appear aligned. In this record, the group comparisons remain uncertain, and they do not resolve the uncertainty in the primary sit-to-stand-to-sit estimate. Nor do they establish that all outcomes moved together or that changes in one measure caused changes in another.

The comparisons are unadjusted, and the registry record does not report a multiplicity procedure or a prespecified hierarchy for interpreting secondary endpoints. When several outcomes are tested, the chance of observing an apparently notable result by chance can increase. That is why unadjusted secondary results generally carry less weight than a clearly prespecified primary comparison, particularly when no analysis plan is reported. These results are best treated as descriptive evidence that may inform future study questions, rather than as stand-alone confirmation of an effect.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Hand-grip Strength
• Estimated GFR
• Quality of Life - Physical Function Domain

9. Statistical Interpretation

10. Statistical Methods Explained

The posted outcome is continuous and summarized as a mean with a standard deviation. The mean is the arithmetic average of the recorded values in a group. The standard deviation describes how spread out those observations are around the group mean. These two quantities answer different questions: the mean describes the group’s central value, while the standard deviation describes variability among observations.

How is the group comparison formed?

The primary comparison is the sodium bicarbonate mean minus the placebo mean. For the sit-to-stand-to-sit measure, the posted group means are 23.8 and 22.9 seconds, and the recalculated difference is 0.9 seconds. A positive difference on this subtraction means the mean time is higher in the sodium bicarbonate group; a negative difference would mean it is lower. The comparison is unadjusted: it does not account for other participant characteristics or measurements in the calculation described by the posted summaries.

In general, a comparison of independent group means uses the group sizes and the variability within each group to quantify uncertainty. The registry record gives 74 participants in the sodium bicarbonate arm and 75 in the placebo arm for the primary summary, as well as a standard deviation for each. The recalculated confidence interval and p-value use those posted summary statistics. The registry record does not report an adjusted model, a covariate set, or a sponsor-reported test statistic.

What does a confidence interval express?

In general, a confidence interval describes a range of effect estimates compatible with the observed data under a specified method. Here, the recalculated interval for the primary mean difference is -1.077 to 2.877 seconds. Because zero lies inside that interval, the comparison does not exclude a zero mean difference at the interval’s stated confidence level. The interval also indicates that the point estimate should not be treated as exact: estimates both below and above zero remain compatible with these data and this calculation.

A confidence interval is not the range of individual participant times, and it does not say that a particular probability attaches to the true effect after the data have been observed. Its width reflects uncertainty in the estimate. In general, more observations and less variability can yield a narrower interval, while fewer observations or more variability can yield a wider one, all else being equal.

What does the p-value add?

The primary unadjusted p-value is 0.372. In general, a p-value measures how unusual data at least as incompatible with a specified null model would be if that model were correct, given the test’s assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. A p-value should be read alongside the effect estimate and its confidence interval, not as a standalone verdict.

The word unadjusted matters because the registry record does not report a correction for testing several outcomes or comparisons. A collection of separate tests can increase the chance that at least one result appears noteworthy by chance. Without a prespecified analysis strategy and multiplicity handling in the registry record, individual unadjusted secondary results deserve cautious interpretation.

How should variability and standardized effects be understood?

The registry also gives standard deviations for each arm and recalculated standardized effect sizes in the comparison data. A standardized effect expresses a mean difference relative to a measure of variability, which can help describe scale-independent magnitude. It does not replace the original units or determine clinical importance. The primary effect-size estimate is 0.146. The registry record does not report a clinical interpretation threshold for this quantity.

General statistical note: over-dispersion refers to variability greater than a model assumes. It can make standard errors too small and confidence intervals too narrow if a model does not account for it. The posted outcomes are continuous group summaries, and no over-dispersion model or diagnostic is reported in the registry record; this general concept should not be taken as evidence that over-dispersion occurred in this trial.

What do the planning calculations represent?

The planning illustrations use the observed effect as a reference and consider stated fractions of that effect. They assume a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. In general, a power calculation estimates how many participants would be needed under specified assumptions to have a stated chance of detecting an effect of a chosen size if that effect were present. Those illustrations do not describe the trial’s original design justification, which is not reported in the registry record. They are not observed power and cannot establish whether the trial was designed appropriately.

The calculations are especially sensitive to the effect size selected. A smaller effect is harder to distinguish from random variation and therefore requires more participants under the same assumptions. The planning values are illustrations rather than guarantees: actual precision depends on the variability, outcome completeness, analysis method, and other features of a future study. Those aspects are not fully specified in the registry record.

11. Confidence Intervals and Precision

The primary mean difference is 0.9 seconds, with a 95% confidence interval from -1.077 to 2.877 seconds. The interval extends from a possible lower mean time in the sodium bicarbonate group to a possible higher mean time. Since it includes zero, the estimate is compatible with no average difference as well as with differences in either direction. The data therefore leave uncertainty about both direction and size.

The estimate is based on the posted group summaries, not a reported adjusted analysis. The arm standard deviations are 5.8 seconds and 6.5 seconds, while the group sizes listed are 74 and 75. Variation among participants is substantial relative to the mean difference, and the confidence interval conveys the resulting uncertainty in the comparison. This description does not imply that any particular participant’s result falls near the group mean.

In general, a confidence interval is more informative than a point estimate alone because it displays a range of values compatible with the data under the calculation method. It is not a guarantee that the true effect lies inside the interval, nor does it establish clinical relevance. The registry record does not report a threshold for a meaningful difference in task time, so the clinical importance of values within the interval cannot be determined from the posted record.

The interval also does not account for uncertainties that are outside its calculation, such as unreported missing-data procedures, possible deviations from the planned analysis, or multiple-outcome testing. No confidence interval from an adjusted sponsor analysis is reported in the registry record. These limits matter when translating numerical precision into a broader interpretation.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm for 80% power and participants per arm for 90% power. They are not total event counts: this is a continuous-outcome setting, and the calculations are expressed as participants in each of two arms. The assumptions listed are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set as a stated fraction of the observed effect.

In plain language, the 80% power column gives an illustrative per-arm sample size for a design that, under the stated assumptions and if the chosen effect were real, would detect that effect in 80% of repeated studies. The 90% power column uses a higher target chance of detection under the same general planning framework. Higher target power requires more participants for a given effect size. These statements are properties of the planning calculation, not promises about the outcome of an individual study.

Rows for smaller fractions of the observed effect require more participants because smaller differences are harder to distinguish from random variation. The planning assumptions for the original trial, including its own target effect and sample-size justification, are not reported in the registry record. The displayed calculations are based on the observed effect and are not observed power.

Planning values should be read as conditional illustrations, not as proof that a future study will achieve its target. The calculation depends on assumptions about allocation, variability, significance level, and the effect chosen to detect. A design with different assumptions, incomplete outcome data, or a different analysis could require different numbers. These calculations do not alter the interpretation of the posted trial estimates.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.900; pooled standard deviation σ = 6.162.
2. n = 2 × (1.96 + 0.842)² × 6.162² / 0.900² = 735.9, rounded up to 736 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.900000000000002                      # observed difference in means
sigma <- 6.16232794601892                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1452412)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 736 (80% power), 986 (90% power)
 75% of observed effect: n per arm = 1,309 (80% power), 1,752 (90% power)
 50% of observed effect: n per arm = 2,944 (80% power), 3,941 (90% power)
power.t.test: 736.9 
Simulated power at n = 736 per arm: 0.795 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary endpoint and lists three secondary outcomes. It also reports five outcome measures overall, while only three secondary outcomes are listed in the posted secondary results. The relationship between that total and the outcomes available in the record is not reported in the registry record. The record does not report a multiplicity adjustment, a testing hierarchy, or a procedure for controlling the overall error rate across outcomes.

Multiplicity is a general concern when many hypotheses are tested. Even when no real group differences exist, repeated testing can make at least one result appear unusual by chance more often than a single test would. An analysis plan may address this through prespecified primary and secondary outcomes, adjustment procedures, or a structured interpretation strategy. Such details are not reported in the registry record, so the unadjusted p-values should not be read as if they account for all outcome testing.

Missing-data handling is also not reported in the registry record. The posted arm summaries list 74 and 75 participants for the primary measure, but the record does not explain whether those counts represent all assigned participants, those with a measurement at 2 year, or a defined analysis population. It does not report reasons for missing measurements, imputation methods, sensitivity analyses, or how withdrawals and nonadherence were handled.

The analysis population is not identified as intention-to-treat, per-protocol, or another defined set. The registry record also does not report baseline-adjusted models, interim analyses, stopping rules, or a detailed statistical analysis plan. These omissions limit assessment of whether the posted summaries follow a prespecified approach and how robust the estimates are to missing information or analysis choices. They do not establish that any particular method was or was not used; the details are simply not reported in the registry record.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: all-cause hospitalization (27.0%).

The registry lists 20 participants affected by serious adverse events among 74 in the sodium bicarbonate group and 15 among 75 in the placebo group. It lists other adverse events affecting 29 participants in the sodium bicarbonate group and 41 in the placebo group. One death is listed for the sodium bicarbonate group and none for placebo. These are descriptive counts in the registry record; they do not by themselves establish that an event was caused by the assigned treatment.

All-cause hospitalization is listed as the top serious adverse event term, with 27.0%. The record does not provide further context for that percentage in the information available, such as the denominator or event-level detail. The registry also does not report event timing, severity categories beyond the serious classification, duration, recurrence, attribution, or a statistical comparison of safety outcomes.

Counts of participants affected and counts of events are not necessarily the same: one participant may experience more than one event, but the record does not give enough detail to assess recurrence. These summaries should be interpreted as reported safety information rather than a complete comparative safety analysis. The group totals differ, and without fuller follow-up and event definitions, simple count comparisons cannot establish a causal risk difference.

16. What the Result Does, and Does Not, Mean

The posted primary estimate describes a small positive mean difference in time, with the sodium bicarbonate group taking longer on average than the placebo group on the sit-to-stand-to-sit task. Its confidence interval includes zero and extends in both directions. Consequently, the registry summaries do not establish a clear average difference on this endpoint, while also leaving uncertainty about the range of effects compatible with the data.

This is not the same as proving that the groups were equivalent. Demonstrating equivalence or non-inferiority would require a prespecified margin and an analysis designed for that question; such a margin and analysis are not reported in the registry record. A non-significant unadjusted p-value also does not prove there is no effect. It indicates that this comparison did not provide strong evidence against the no-difference model under the stated calculation.

The estimate concerns average performance on a particular repeated movement task at 2 year. It does not directly answer whether participants experienced meaningful changes in daily life, whether individual responses varied, or whether other aspects of health changed. The registry record does not report a minimum clinically important difference or enough measurement detail to make those judgments.

Nor do the posted results determine effects on all of the concerns described in the trial rationale. The registry lists secondary results for grip strength, estimated GFR, and physical-function quality of life, but those are separate outcomes and do not combine into a single conclusion about muscle, bone, glucose metabolism, or kidney health. The record does not report results for every domain mentioned in the rationale.

The results also do not establish effects beyond the stated two-year endpoint, among populations not described in the registry, or under treatment schedules different from the listed regimen. In general, trial results apply most directly to the participants, intervention, comparator, outcome definitions, and follow-up represented in the record. Further clinical interpretation would require information and analyses that are not reported in the registry record.

17. Why This Trial Matters Statistically

This trial is statistically informative because it presents a continuous primary outcome with group means, standard deviations, and group sizes. These summaries allow an unadjusted estimate of the difference in means and an assessment of its uncertainty. The point estimate alone could invite an overly definite reading; the confidence interval shows why the uncertainty around that estimate matters.

The trial also illustrates the distinction between statistical evidence and clinical importance. A p-value does not describe the magnitude of an effect, while a confidence interval does not identify which differences would matter to patients. The registry record gives no threshold for a meaningful task-time difference. Statistical interpretation therefore needs both the numerical estimate and an understanding of what the measure represents, without treating either as a complete clinical judgment.

Another important issue is the gap between observed estimates and study planning. The registry record provides illustrative sample-size calculations based on the observed effect, but does not report the trial’s original sample-size assumptions. Planning calculations can show how sample size depends on the effect one hopes to detect; they cannot retrospectively demonstrate that a study had a particular probability of finding its observed result.

Finally, the record highlights how much interpretation depends on analysis details. Outcome multiplicity, missing measurements, analysis populations, and covariate adjustment can affect the meaning and precision of estimates. Because these details are not reported in the registry record, the available comparisons are best understood as descriptive, unadjusted evidence. Clear reporting of the prespecified plan and the handling of incomplete data would make the statistical conclusions easier to evaluate.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record contains limited information about trial procedures and statistical methods. Eligibility criteria, recruitment details, allocation concealment, the specific roles included in quadruple masking, adherence, and participant flow are not reported in the registry record. Without those details, it is difficult to assess how closely the posted results represent the randomized groups and how the trial was implemented.

The primary and secondary results are reported as group means and standard deviations at 2 year. The record does not say whether these values are endpoint measurements or changes from baseline, and it does not provide baseline outcome summaries in the listed results. It also does not describe adjusted analyses or provide a detailed statistical analysis plan. Comparisons recalculated from summaries do not replace a prespecified sponsor analysis, and no sponsor-reported analyses are listed.

For the outcome data, missingness, reasons for missing measurements, imputation, and sensitivity analyses are not reported in the registry record. The analysis population is not defined. These omissions limit evaluation of possible bias from incomplete follow-up and prevent a full assessment of robustness.

There is no reported clinical threshold for meaningful differences on the primary endpoint, no described assessment protocol beyond the task definition, and no stated multiplicity approach for the outcomes. The record’s total outcome-measure count also does not fully correspond to the set of primary and secondary results listed. Finally, safety information is presented as summary counts without event timing, attribution, or detailed event-level comparisons. These limitations constrain interpretation of both the outcome estimates and the safety summaries; they do not establish that a particular bias or harm occurred.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Alkali Therapy in Chronic Kidney Disease — NCT01452412.
• Registry record last updated 2020-01-07; status last verified 2019-12.
• Results first posted 2020-01-07.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

NCT01452412 is a completed randomized, placebo-controlled, parallel-group trial of sodium bicarbonate in chronic kidney disease and metabolic acidosis. The record lists phase 2 and phase 3, quadruple masking, enrollment of 149, and Albert Einstein College of Medicine as sponsor. The primary endpoint is time to complete sit to stand to sit 10 times, measured in seconds at 2 year.

The posted primary means are 23.8 seconds for sodium bicarbonate and 22.9 seconds for placebo. The recalculated mean difference is 0.9 seconds, with a 95% confidence interval from -1.077 to 2.877 and an unadjusted p-value of 0.372. The interval includes zero, leaving uncertainty about the direction and size of the group difference.

Three secondary outcomes and summary safety counts are also listed. Adjusted analyses, multiplicity handling, missing-data methods, analysis populations, and the trial’s original sample-size assumptions are not reported in the registry record. The posted summaries support descriptive comparisons, but the record does not provide enough methodological detail to make a comprehensive assessment of the analysis.