This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for The Impact of Neut During Potassium Chloride Replacement on Pain and Incidence of Phlebitis (NCT02082717), a randomized phase 4 study. The primary outcome is Number of Participants With Indicated Findings.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02082717 |
| Phase | Phase 4 |
| Condition | Hypokalemia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 17 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Baptist Health South Florida |
| Results posted | Yes |
2. Clinical Question
Population
The intended population was adults aged 21 years or older who were alert, awake, and oriented at enrollment, had an order for peripheral intravenous potassium chloride replacement, and were recruited from a Medical/Surgical unit during the first 24-48 hours of admission. Hypokalemia is the listed condition. These criteria describe the planned study population; the registry record does not report how many enrolled participants met each criterion or provide further baseline characteristics.
Intervention
The experimental approach was 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement. The registry record calls this arm “Neut (4%sodium bicarbonate additive).” It does not provide additional details about the preparation, dose, or administration beyond the additive and replacement therapy description.
Comparator
The control approach was standard-of-practice potassium chloride replacement with no sodium bicarbonate additive. Both groups received potassium chloride replacement; the recorded contrast is the addition of 4% sodium bicarbonate versus no additive. Further details about care procedures in either group are not reported in the registry record.
Primary question
The study asked whether adding 4% sodium bicarbonate during peripheral intravenous potassium chloride replacement was associated with differences in pain or phlebitis, along with findings involving changes in IV access and administration time. The primary outcome is registered as the number of participants with indicated findings, assessed up to 4 hours. The record does not provide category-specific counts, a comparative effect estimate, or an analysis of these outcomes, so it does not establish how the groups compared.
3. Trial Design
The study is registered as a Phase 4, randomized, double-blinded, parallel-group controlled study sponsored by Baptist Health South Florida. Its title describes a study of 4% sodium bicarbonate additive during potassium chloride replacement for adult patients in a Medical/Surgical unit. The registered intervention arms are the bicarbonate-additive approach and standard potassium chloride replacement without an additive.
The registry lists enrollment of 17 and records the study status as terminated. The recorded start date is 2014-02-25, and the primary completion date is 2018-08-03. The registry does not state why the study was terminated, whether recruitment ended as planned, or whether the recorded enrollment was the intended target. A rationale for the planned sample size is not reported in the registry record.
Randomization and double masking are registered design features. The record does not explain how the random sequence was generated, how treatment assignments were concealed, or which people were masked. It also does not describe steps used to maintain masking during preparation or delivery of the additive. The parallel model indicates that participants were assigned to one of the two registered approaches rather than crossing between them; further details about allocation and follow-up are not reported.
The planned population included adults aged 21 years or older who were alert, awake, and oriented at enrollment and had an order for peripheral intravenous potassium chloride replacement. Recruitment was described as taking place in one Medical/Surgical unit during the first 24-48 hours of admission. The primary outcome timeframe is up to 4 hours. The record names nursing interventions and attrition rates as secondary outcomes, but does not report their results or specify further measurement schedules.
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
| Stage | Neut (4%Sodium Bicarbonate Additive) | Control |
|---|---|---|
| STARTED | 8 | 9 |
| COMPLETED | 8 | 9 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Due to the small number of participants enrolled, the statistical power would be too low for any significant findings.
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.
| Characteristic | Unit | Neut (4%Sodium Bicarbonate Additive) | Control | Total |
|---|---|---|---|---|
| Participants analysed | 8 | 9 | 17 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 | 4 | 9 |
| Age, Categorical: >=65 years | Participants | 3 | 5 | 8 |
| Sex: Female, Male: Female | Participants | 6 | 9 | 15 |
| Sex: Female, Male: Male | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 6 | 9 | 15 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Indicated Findings, measured over Up to 4 hours.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is registered as the number of participants with indicated findings, with a timeframe of up to 4 hours. The description names phlebitis, pain at the peripheral intravenous insertion site, frequency of changing IV access, and time for administration. It contrasts potassium chloride replacement with 4% sodium bicarbonate additive against standard replacement without the additive.
Counting participants with an event or finding is a way to describe how often a defined outcome occurs. For a binary outcome, each participant is classified according to whether the finding was present or absent under the specified definition and observation period. This approach can be useful for outcomes such as the presence of pain or phlebitis, but interpretation depends on clear definitions, consistent assessment, and complete outcome recording. The registry record does not provide operational definitions, thresholds, or assessment procedures for the listed findings.
The outcome description combines findings that are not necessarily the same kind of measure. Pain and phlebitis are distinct clinical observations, while changing IV access and administration time describe care processes. The record does not specify whether these were treated as separate categories, how the categories were handled, or how a participant with more than one finding would be counted. The primary outcome is therefore not reducible from the registry record to one simple comparison. Category-specific participant counts and comparative estimates are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the question and design but does not supply a comparative primary-outcome result. It names pain, phlebitis, IV access changes, and administration time, yet gives no category-specific counts, effect estimate, confidence interval, or analysis result for these outcomes. The record lists zero analyses. Consequently, the posted results do not show whether the groups differed on the primary outcome, nor how precise any difference might be.
The record itself notes that the small number of participants enrolled would leave statistical power too low for significant findings. This is an important caution about the capacity of the study to detect differences, but it is not a result showing that the groups were equivalent. A nonsignificant result, if one had been reported, would not by itself establish no effect; in this record, comparative significance testing is not reported at all.
The safety information is separate from the primary outcome. In the bicarbonate-additive group, 8 participants were listed as at risk for serious adverse events and 0 as affected; the same group had 8 listed at risk for other adverse events and 0 affected. In the control group, 9 were listed at risk for serious adverse events and 0 as affected, and 9 were listed at risk for other adverse events and 0 affected. Deaths are listed as 0 in each group. These figures describe the registry's adverse-event entries, not evidence that every possible harm was assessed or absent.
The registry lists the study as terminated, but does not report the reason. It is not possible to tell from the record whether termination was related to recruitment, operational considerations, safety, or another cause. Nor does the record state whether the listed enrollment represents everyone randomized, whether all participants completed follow-up, or whether outcome data were available for each person.
Overall, the available information is descriptive and incomplete for judging the intended clinical comparison. Enrollment was limited, the record explicitly warns of low power, and primary-outcome estimates are unavailable. The findings should therefore be read as an incomplete registry record rather than as evidence for or against the comparative effects of the two approaches.
9. Statistical Methods Explained
What does randomization contribute?
In general, randomization assigns participants to study groups using a chance-based process. Its purpose is to reduce systematic differences between groups at the point of assignment, including differences that are not measured or known to investigators. It does not guarantee that the groups will be similar in every characteristic, especially in a small study. This registry identifies the design as randomized, but the method used to create the allocation sequence and conceal assignments is not reported in the registry record.
What does double masking mean?
In general, masking is intended to limit the influence of knowledge about assignment on care, outcome assessment, or participant reporting. “Double” is the registry's masking designation, but the record does not identify which participant, clinician, assessor, or other role was masked. It also does not explain how masking was implemented. This matters particularly for outcomes such as pain, where the process of asking about or recording symptoms may affect measurement. The record does not describe the pain assessment method.
How should participant counts be understood?
The primary outcome is described in terms of participants with indicated findings. In general, a binary outcome records whether an event or characteristic is present or absent for each participant. The count alone is not a complete comparison: interpretation also depends on the number of participants assessed in each group, the event definition, the follow-up period, and missing outcome data. Although the registry gives an outcome timeframe of up to 4 hours and describes the intended outcome categories, it does not report the corresponding category-specific participant counts or comparative analysis.
For two groups, an effect estimate expresses the observed contrast using a chosen scale, such as a difference in event proportions or a relative measure. A confidence interval describes the range of values reasonably compatible with the observed data under the statistical model. In general, a wider interval reflects greater uncertainty, while a narrow interval indicates more precision. Neither an effect estimate nor a confidence interval for the primary outcome is reported in the registry record, so the magnitude and precision of a group contrast cannot be assessed.
Why does low enrollment matter?
In general, statistical power is the chance that a study will identify a specified effect as statistically significant when that effect is present, under the assumptions used for planning. Power depends on factors including the true effect, outcome frequency, variability, sample size, and analysis method. Small enrollment usually limits the range of effects a study can distinguish reliably. The registry explicitly states that the number enrolled was too small for statistical power to support significant findings. That statement is a caution about the study's capacity, not a substitute for an estimate of effect or uncertainty.
Planning sample sizes from an observed effect is different from a trial's original sample-size justification. The registry describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; the target effect is expressed as a stated fraction of the observed effect. Such illustrations are hypothetical planning aids, not observed power and not evidence that the study was designed to detect those effects. They should not be read as a replacement for the trial's original design rationale, which is not reported in the registry record.
Why can over-dispersion matter?
In general, count outcomes may vary more than a simple statistical model expects. This is called over-dispersion. If present and not handled appropriately, it can make standard errors too small and confidence intervals too narrow, overstating precision. The registered primary outcome is a count of participants with findings, but the record does not describe a count model, an over-dispersion assessment, or any analysis method. This general issue should not be taken to imply that over-dispersion occurred in this study.
What does the record say about analysis?
The registry lists no analyses. It does not report a statistical analysis plan, a test or model for the primary outcome, adjustment for baseline characteristics, a method for handling repeated or multiple findings, or a prespecified approach to missing data. Because the primary description includes several types of findings, a single overall estimate cannot be reconstructed from the information reported. Any recalculation from posted summary statistics would require those statistics and cannot replace a sponsor analysis; no sponsor comparative analysis is reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description names multiple findings: phlebitis, pain at the peripheral intravenous insertion site, frequency of changing IV access, and time for administration. The record does not state whether these were separate endpoints, categories within one endpoint, or components of a combined measure. It also does not identify a primary category among them or describe how comparisons across multiple outcomes would be handled. Because examining multiple outcomes can increase the chance of a chance-positive result, a prespecified strategy for multiplicity is important. Such a strategy is not reported in the registry record.
The secondary outcomes are listed as number of participants nursing interventions and attrition rates. Their definitions, assessment windows, results, and analysis methods are not reported. The record provides no statistical analysis plan and lists no analyses, so it is not possible to determine which outcome comparisons were planned or conducted, or whether any adjustment was intended.
Missing-data handling is also not reported in the registry record. Although attrition rates are listed as a secondary outcome, no attrition results are provided. The record does not state how many participants had primary-outcome assessments, whether follow-up was complete, how missing values were treated, or whether an analysis population was defined. It does not identify intention-to-treat, per-protocol, or other analysis populations.
These gaps matter because outcome estimates can depend on which participants are included and how incomplete measurements are handled. Without endpoint definitions, outcome counts, missingness information, and an analysis plan, the primary comparison cannot be reconstructed or evaluated for robustness.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Neut (4%Sodium Bicarbonate Additive) | 0 | 8 | 0.0% |
| Control | 0 | 9 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Neut (4%Sodium Bicarbonate Additive) | 0 of 8 |
| Control | 0 of 9 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Neut (4%Sodium Bicarbonate Additive) | 0 of 8 |
| Control | 0 of 9 |
The registry reports serious and other adverse events by group. For the bicarbonate-additive group, 8 participants were listed at risk for serious adverse events, with 0 affected; 8 were listed at risk for other adverse events, with 0 affected. For the control group, 9 were listed at risk for serious adverse events, with 0 affected; 9 were listed at risk for other adverse events, with 0 affected. The registry lists 0 deaths in each group.
These entries mean that no events were recorded in the registry's reported serious or other adverse-event fields for the listed groups. They do not establish that all potential adverse events were systematically sought, that all participants had complete safety follow-up, or that the two approaches have equal safety. The record does not define the surveillance period for these safety entries, describe event-collection procedures, or list specific adverse-event terms. The absence of reported events should therefore be interpreted within the limits of the available registry information, not as proof that no harm could occur.
12. What the Result Does, and Does Not, Mean
The record describes a randomized, double-blinded comparison of potassium chloride replacement with and without 4% sodium bicarbonate additive. It reports enrollment of 17 and marks the study as terminated. It also names the intended outcomes and provides limited adverse-event counts. These details help clarify what the study set out to examine, but they do not provide a comparative answer to the primary question.
There are no category-specific primary-outcome results, no effect estimate, no confidence interval, and no analysis result in the registry record. Without these, readers cannot determine the direction or magnitude of any group difference or the precision of an estimate. The registry's statement that statistical power was too low for significant findings reinforces that the small enrollment limits what the study could establish. Lack of a reported significant result is not evidence that the approaches were equivalent; the comparative result itself is not reported.
The adverse-event entries show zero reported serious events, zero reported other events, and zero deaths in both groups, with the group-specific at-risk counts recorded. Those entries are reassuring only as a description of what the registry reports; they do not demonstrate absence of all possible harms or provide a complete safety comparison.
The study's termination status adds uncertainty about its completion, but the reason for termination is not reported in the registry record. The record also does not supply the planned sample-size rationale, detailed analysis methods, endpoint definitions, or missing-data procedures. Taken together, these omissions mean the posted information is insufficient to draw a firm conclusion about comparative pain, phlebitis, IV access changes, administration time, or safety. The appropriate interpretation is that the registry records a small terminated study with no reported comparative primary-outcome analysis.
13. Why This Trial Matters Statistically
This study illustrates a central statistical challenge in small clinical trials: a carefully described question and randomized design do not ensure that the results will be precise enough to answer it. The registry identifies the intended contrast, the target population, and several clinically relevant findings. Yet enrollment was 17, and the record itself states that statistical power would be too low for significant findings.
That limitation is not simply a matter of whether a statistical test crosses a threshold. Small studies can produce estimates with substantial uncertainty, and results may be sensitive to a small number of observations. For meaningful interpretation, readers need outcome counts and an estimate of the size and precision of the group contrast. Those primary-outcome results are not reported in the registry record, so neither statistical significance nor clinical importance can be evaluated from the posted information.
The outcome description also highlights the value of clear endpoint specification. Pain, phlebitis, changes in IV access, and administration time are different types of findings. The registry does not explain whether they were analyzed separately or combined, or how multiple comparisons were addressed. Clear definitions and a prespecified analysis plan help readers understand what was measured, how evidence was evaluated, and whether conclusions match the study question.
Finally, the terminated status and absent analysis details show why registry status and results must be read together. A record can document an intended randomized comparison without offering the evidence needed to estimate its effects. Here, the main statistical lesson is the distinction between a study design and an interpretable result: design features establish the planned comparison, while outcome data and transparent analysis are needed to quantify what the study found.
14. 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.
Several trial-specific limitations constrain interpretation. The registry records enrollment of 17 and explicitly states that the number of participants was too small for statistical power to support significant findings. It does not report a planned enrollment target or a sample-size justification, so it is not possible to assess how the recorded enrollment compares with the original plan.
The study is marked terminated, but the reason is not reported in the registry record. There is no account of recruitment progress, completion, or whether termination affected outcome collection. The record also does not provide participant flow, baseline characteristics, or the number with observed primary outcomes. Attrition rates are listed as a secondary outcome but no corresponding result is reported.
The primary description includes several findings and does not provide operational definitions or separate results for them. It is unclear how pain, phlebitis, IV access changes, and administration time were assessed, whether each was analyzed separately, or how participants with multiple findings were counted. The registry does not report a statistical analysis plan, analysis population, missing-data method, or multiplicity strategy.
Although randomization and double masking are registered, the methods used to implement them are not described. The record does not explain allocation concealment, who was masked, or whether masking was maintained. Finally, the safety entries do not include specific event terms or surveillance details. These limitations leave the design identifiable but the comparative efficacy and safety findings insufficiently documented.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Impact of Neut During Potassium Chloride Replacement on Pain and Incidence of Phlebitis — NCT02082717.
- Registry record last updated 2021-04-01; status last verified 2021-03.
- Results first posted 2021-04-01.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02082717 is registered as a Phase 4 randomized, double-blinded, parallel-group study sponsored by Baptist Health South Florida. It examined 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement compared with standard replacement without an additive in adults in a Medical/Surgical unit. The registered population was adults aged 21 years or older, alert, awake, and oriented, with an order for peripheral intravenous potassium chloride replacement.
The registry reports enrollment of 17, a study status of terminated, a start date of 2014-02-25, and a primary completion date of 2018-08-03. The primary outcome concerned participants with indicated findings up to 4 hours, including phlebitis, pain, IV access changes, and administration time. Nursing interventions and attrition rates were listed as secondary outcomes. Comparative primary-outcome results and analyses are not reported in the registry record. The record notes that statistical power was too low for significant findings.