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 Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease (NCT03141905), a randomized na study. The primary outcome is Change in Renal Function From Baseline to Study Completion;.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03141905 |
| Phase | NA |
| Condition | Safety Issues, Chronic Kidney Diseases |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 342 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of Maryland, Baltimore |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with chronic kidney diseases and enrolled 342 participants. The primary outcome is described for 280 participants with complete laboratory data collection. The registry record does not report further eligibility details or describe the characteristics of the enrolled participants.
Intervention
The intervention was a Sick-Day Protocol. Participants received instructions for holding and resuming certain medicines during dehydrating illness, together with weekly remote monitoring using an automated phone survey. The protocol was intended to guide temporary medication changes when illness might cause volume depletion.
Comparator
The comparison group received usual care, described as standard clinical care. The registry record does not provide a more detailed account of care in this group or indicate whether other aspects of care were standardized.
Primary question
The primary question was whether the protocol was associated with a different change in renal function from study entry to completion, measured using creatinine. The registry record also describes interest in acute kidney injury episodes and preventable service use, including emergency room use and hospitalization. The posted primary outcome is a within-arm median change; a direct estimated contrast between the arms is not reported in the registry record.
3. Trial Design
This was a randomized, parallel-group study with no masking listed in the registry record. It compared the Sick-Day Protocol with usual care. The trial is listed as completed, with enrollment of 342 participants. The recorded start date is 2017-10-16, and the primary completion date is 2020-10-07. The phase is listed as NA. The sponsor was University of Maryland, Baltimore.
The intervention combined sick-day medication instructions with weekly remote monitoring. The instructions concerned holding and resuming certain medicines during dehydrating illness. The usual-care arm is described as standard clinical care. The registry record does not report further details about implementation, adherence monitoring, treatment crossover, or whether participants in usual care received similar illness-management instructions.
The primary outcome was change in renal function from baseline to study completion, assessed through laboratory creatinine measurements at study entry and completion. The listed timeframe is 6 months (enrollment to study completion). The primary outcome results cover 280 participants with complete laboratory data collection. The record does not explain why complete laboratory results were unavailable for other enrolled participants, or how the complete-data group was selected for analysis.
Acute kidney injury incidents and emergency room use and hospitalization are named as secondary outcomes. The record lists five outcome measures overall, but it does not give posted analyses for the primary comparison. It records zero analyses. Consequently, the design features establish how the arms were organized and what was intended to be assessed, but the registry record does not give a full statistical analysis plan or a detailed account of how each outcome was analyzed.
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 | Sick-Day Protocol | Usual Care |
|---|---|---|
| STARTED | 176 | 166 |
| COMPLETED | 152 | 147 |
| NOT COMPLETED | 24 | 19 |
Reasons for not completing this period:
| Reason | Sick-Day Protocol | Usual Care |
|---|---|---|
| Death | 3 | 2 |
| Withdrawal by Subject | 1 | 0 |
| Lost to Follow-up | 3 | 7 |
| Randomized, but did not receive intervention. Withdrew prior to baseline visit. | 17 | 10 |
Analysis population for the primary outcome, as defined in the registry: 280 participants with complete laboratory data collection
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 | Sick-Day Protocol | Usual Care | Total |
|---|---|---|---|---|
| Participants analysed | 159 | 156 | 315 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 29 | 37 | 66 |
| Age, Categorical: >=65 years | Participants | 130 | 119 | 249 |
| Sex: Female, Male: Female | Participants | 7 | 7 | 14 |
| Sex: Female, Male: Male | Participants | 152 | 149 | 301 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 1 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 158 | 155 | 313 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 100 | 99 | 199 |
| Race (NIH/OMB): White | Participants | 58 | 56 | 114 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 159 | 156 | 315 |
| eGFR | ml/min/1.73m^2 | 43.110 (SD 13.128) | 43.783 (SD 13.018) | 43.441 (SD 13.057) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Renal Function From Baseline to Study Completion;, measured over 6 months (enrollment to study completion).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | mg/dL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the change in renal function from baseline to study completion, measured using creatinine in mg/dL. Laboratory creatinine was measured at study entry and completion, and the stated timeframe is 6 months (enrollment to study completion). Results are reported as medians with 95% confidence intervals. The analysis population is described as 280 participants with complete laboratory data collection.
Creatinine is a laboratory measure used to assess kidney function. In general, repeated measurement can describe how a laboratory value changes over a follow-up period. A median summarizes the central position of the observed values and is less affected by unusually high or low values than an arithmetic mean. The registry record does not specify the exact calculation order for the change, so the direction of a positive or negative value should not be assigned beyond the registry’s description.
The endpoint was selected to assess renal function over the study period, which is relevant to the study’s stated interest in kidney function loss and acute kidney injury. However, a change in creatinine is not the same as a direct count of acute kidney injury episodes, emergency visits, or hospitalizations. Those outcomes are named separately as secondary outcomes. The record does not report a direct between-arm estimate or statistical test for the primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the Sick-Day Protocol arm, the posted median change in creatinine was 0.01 mg/dL, with a 95% confidence interval from -0.11 to 0.22. For usual care, the posted median change was 0.02 mg/dL, with a 95% confidence interval from -0.01 to 0.21. These are arm-specific summaries. They do not, by themselves, give the estimated difference between the arms.
Both confidence intervals extend across zero. This indicates that the reported intervals include values on either side of zero for each arm’s median change. A confidence interval describes uncertainty around an estimate under the analysis assumptions; it is not a range in which every participant’s result lies. The registry record does not report the method used to construct these intervals, a direct contrast between arms, or a test of the treatment comparison. No p-value for the primary comparison is reported in the registry record.
The values should therefore be read as descriptive evidence about the reported median changes among participants with complete laboratory data. The posted medians are close in numerical value, but interpreting a treatment effect requires a direct between-arm estimate and its uncertainty. A numerical comparison of arm-specific medians is not a substitute for that estimate, and no new contrast is calculated. The record also does not state how the change was coded, so the signs should not be translated into a definite increase or decrease in creatinine without that definition.
The primary analysis population includes 280 participants with complete laboratory data, while total enrollment was 342. The registry record does not describe the missing laboratory data, the analysis population for other outcomes, or whether statistical adjustments were used. These omissions limit assessment of how representative the complete-data results are and how precisely they answer the randomized comparison.
The posted safety counts show zero serious adverse events recorded as affecting participants in each arm. Other adverse events were recorded for 7 participants in the Sick-Day Protocol arm and 3 in usual care. Deaths were recorded for 3 participants and 2 participants, respectively. These counts are descriptive; the registry record does not state whether events were judged related to the intervention, provide event timing, or give a comparative safety analysis.
Overall, the posted results describe arm-specific medians and selected event counts, not a complete inferential analysis of whether outcomes differed between groups. The absence of a reported between-arm estimate, test, and analysis details means the registry record supports a cautious description of the observed summaries, rather than a firm conclusion about the magnitude or precision of a comparative effect.
9. Statistical Methods Explained
The methods information in the registry record is limited. It identifies random allocation, no masking, a parallel-group model, the primary endpoint, and the form of its summary. It does not report the detailed statistical analysis plan. The distinctions below explain how to interpret the reported summaries without treating unreported methods as known.
What does a median describe?
In general, a median is the middle value after observations are ordered. It describes the center of a distribution without relying on the arithmetic average. This can be useful when a measure is skewed or contains extreme observations. The primary outcome is explicitly reported as a median, with creatinine change measured in mg/dL. The registry record does not give the distribution of individual changes, so it is not possible to assess the shape of the data from the reported summary alone.
A median for each arm is a separate summary. The difference between arm-specific medians is not necessarily the same as a model-based estimate of a treatment contrast, and it does not account for uncertainty in the comparison by itself. For a randomized trial, a direct between-arm estimate would describe the comparative effect more directly. Such an estimate is not reported in the registry record.
How should the confidence intervals be read?
In general, a confidence interval expresses statistical uncertainty around an estimated quantity under the assumptions of the method used. A narrower interval indicates greater precision than a wider interval for the same type of estimate. The intervals posted for the primary outcome are 95% confidence intervals for the arm-specific medians. They are not stated to be intervals for the difference between arms, and the method used to obtain them is not reported in the registry record.
The intervals for both arms extend across zero. That observation is descriptive of the reported limits; it does not establish whether a between-arm effect is present or absent. To assess the comparative question, readers would need the direct estimated contrast and its uncertainty, with the analysis method clearly described. Neither is reported in the registry record. A confidence interval also does not mean that the true value has a 95% probability of lying inside the particular interval after it has been calculated. In general, the confidence level describes the long-run behavior of the interval procedure under its assumptions.
What does randomization contribute?
In general, random allocation is intended to create groups that are comparable on average at the point of assignment, including with respect to measured and unmeasured factors. It does not ensure that every characteristic is balanced in a particular trial, and it does not remove the need to describe the analysis. The registry record identifies the study as randomized but does not report the allocation sequence method, concealment procedures, stratification, or balance of participant characteristics. Those details are not reported in the registry record.
The study is described as parallel-group and unmasked. In general, a parallel-group design assigns participants to a group that receives its assigned strategy over the study period. Lack of masking can matter when knowledge of assignment might affect behavior, assessment, or reporting. The registry record does not describe outcome assessor masking or procedures intended to limit bias in laboratory measurement, self-management, or service-use reporting.
What does the planning illustration represent?
The registry’s statistical planning illustration is described as based on the observed effect, rather than the trial’s own design. It assumes a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. In general, such calculations describe hypothetical sample sizes under chosen assumptions. They are planning illustrations and are not observed power, nor do they establish that the original study was designed around those assumptions. The registry record does not report the original sample-size justification.
The record also does not report whether interim analyses were planned or conducted. It does not provide a full specification of the statistical model, covariate adjustment, handling of repeated measures, or rules for excluding observations. These omissions matter because analytic choices can affect estimates and uncertainty, particularly when the outcome is summarized by a median and the primary analysis includes only participants with complete laboratory data.
Why does over-dispersion matter in general?
For count outcomes, a statistical model may assume a particular relationship between the mean and variability. Over-dispersion means that the observed variability is greater than that assumed by a simpler model. If it is ignored, uncertainty estimates can be too small and tests can appear more precise than warranted. This is a general consideration for count outcomes such as event counts; the registry record does not report the model used for acute kidney injury incidents or other event outcomes, nor whether over-dispersion was assessed.
Because no detailed analyses are posted, these methodological concepts should be treated as general context, not as a description of methods known to have been used in this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists five outcome measures and names acute kidney injury incidents and emergency room use and hospitalization as secondary outcomes. It records zero analyses. No adjustment for multiple testing, hierarchy among outcomes, or prespecified strategy for interpreting multiple endpoints is reported in the registry record. When a study examines multiple outcomes, the chance of at least one apparently unusual result can increase if each is interpreted independently. In general, a prespecified testing strategy can clarify which outcomes are confirmatory and how multiplicity is handled. The record does not establish whether such a strategy existed.
The primary outcome results cover 280 participants with complete laboratory data collection. Total enrollment was 342. The registry record does not describe the reasons laboratory data were incomplete, whether missingness differed by arm, or whether missing values were imputed. It also does not report sensitivity analyses to assess how missing laboratory results might affect the estimate. Complete-case results can be influenced if participants with available data differ systematically from those without data; whether that concern applies cannot be determined from the registry record.
The analysis population is described for the primary outcome, but the record does not state whether the primary analysis followed intention-to-treat principles or whether participants were analyzed according to assignment. It does not provide analysis populations for the secondary outcomes. Definitions of the outcomes, event ascertainment, follow-up completeness, and the statistical plan are also not reported in the registry record. These are important gaps for understanding both multiplicity and missing-data risks.
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 |
|---|---|---|---|
| Sick-Day Protocol | 0 | 159 | 0.0% |
| Usual Care | 0 | 156 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sick-Day Protocol | 3 of 159 |
| Usual Care | 2 of 156 |
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 |
|---|---|
| Sick-Day Protocol | 7 of 159 |
| Usual Care | 3 of 156 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sick-Day Protocol | Usual Care |
|---|---|---|---|
| Lab Alert: Potassium ≥ 6.1 mEq/dL | Cardiac disorders | 3 of 159 | 1 of 156 |
| Lab Alert: Glucose ≥ 499 mg/dL | Endocrine disorders | 1 of 159 | 2 of 156 |
| Initiation of Hemodialysis | Renal and urinary disorders | 1 of 159 | 1 of 156 |
| Lab Alert: Chloride ≥ 115 mEq/dL | Renal and urinary disorders | 2 of 159 | 0 of 156 |
| Lab Alert: Hemoglobin ≤ 7.5 g/dL | Blood and lymphatic system disorders | 1 of 159 | 0 of 156 |
| Lab Alert: Co2 ≤ 15 mEq/L | Renal and urinary disorders | 1 of 159 | 0 of 156 |
The registry record lists zero serious adverse events affecting participants in the Sick-Day Protocol arm among 159 at risk, and zero in usual care among 156 at risk. It separately records other adverse events affecting 7 participants among 159 at risk in the Sick-Day Protocol arm and 3 among 156 at risk in usual care. Deaths are listed as 3 and 2, respectively. These are counts, not estimates of a comparative risk, and no statistical comparison is reported in the registry record.
The adverse-event categories should be read as the registry presents them. The record does not supply serious-event terms, and it does not explain the relationship, if any, between the separately listed deaths and the adverse-event categories. It also does not report event timing, severity detail for other adverse events, causal attribution, or whether participants could experience more than one event. The figures therefore do not show whether an event was caused by the assigned strategy.
Zero recorded serious events in these groups does not establish that serious events are impossible or that the strategies have identical safety profiles. In general, event counts need to be interpreted alongside follow-up, ascertainment methods, definitions, and uncertainty. Those details are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The posted primary results describe median creatinine change among 280 participants with complete laboratory data. The Sick-Day Protocol arm has a median of 0.01 mg/dL, with a 95% confidence interval from -0.11 to 0.22. The usual-care arm has a median of 0.02 mg/dL, with a 95% confidence interval from -0.01 to 0.21. These summaries describe each arm separately and do not constitute a direct estimate of the difference between the randomized groups.
The registry record does not report a treatment-effect estimate for the primary comparison, a statistical test, or a p-value. It also does not specify the direction used to calculate change. The posted results therefore do not establish the magnitude or precision of a comparative effect, nor do they establish that one strategy is superior or equivalent to the other. Such conclusions would require an appropriate comparison and sufficient detail about the analysis.
The study’s stated purpose included kidney function, acute kidney injury episodes, and preventable service use. The registry record names acute kidney injury incidents and emergency room use and hospitalization as secondary outcomes, but detailed analyses of those outcomes are not reported in the registry record. The available safety counts give event totals, without causal attribution or an inferential comparison.
In general, a registry result is most informative when the outcome definition, analysis population, contrast estimate, uncertainty, missing-data approach, and prespecified analysis are all clear. Several of those details are absent. The record supports description of the posted medians and safety counts, while leaving important questions about comparative effects and analysis methods unresolved. The findings should not be read as evidence that the protocol did or did not improve outcomes.
13. Why This Trial Matters Statistically
This trial raises a useful statistical question about how to evaluate an intervention intended to guide temporary medication changes during dehydrating illness. The study combines a behavioral protocol with weekly remote monitoring, while the primary endpoint is a laboratory change in creatinine. That structure makes it important to distinguish the intervention’s implementation from the endpoint used to assess kidney function.
The randomized parallel-group design is relevant because it frames a comparison between the protocol and usual care. But reporting arm-specific medians alone does not complete that comparison. A direct between-arm estimate, together with an uncertainty interval and a clear analysis method, would help readers judge the size and precision of the contrast. Those items are not reported in the registry record.
The complete-laboratory analysis population is also statistically important. The primary results include 280 participants, whereas enrollment was 342. The registry record does not explain the incomplete laboratory data or describe sensitivity analyses. Missing outcome data can affect the interpretation of randomized comparisons if availability is related to participant characteristics or outcomes.
Finally, the record names secondary outcomes and provides selected adverse-event counts, but it does not provide detailed analyses or a multiplicity strategy. These gaps illustrate why statistical interpretation depends not only on the observed summary values, but also on analysis populations, uncertainty, endpoint definitions, and transparent handling of multiple outcomes. The record is therefore informative about the trial’s design and posted summaries, while leaving the central comparative inference incompletely documented.
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.
The primary limitation for interpreting the posted result is that the creatinine summaries are reported by arm, without a direct between-arm estimate or test. The registry record gives medians and 95% confidence intervals, but does not describe how those intervals were constructed. It also does not state the subtraction order used to define change, which limits interpretation of the sign of each value.
Only 280 participants with complete laboratory data are included in the primary outcome population, compared with total enrollment of 342. The registry record does not explain why laboratory results were incomplete, report missingness by arm, or describe imputation or sensitivity analyses. The effect of missing data on the reported summaries therefore cannot be assessed from the record.
The registry record does not report baseline characteristics, detailed eligibility criteria, allocation concealment, outcome-assessment procedures, adherence to the protocol, or crossover. It does not state whether the primary analysis was intention-to-treat, nor does it provide the analysis populations for secondary outcomes. Detailed statistical methods, sample-size justification, interim analyses, and a plan for multiplicity are not reported in the registry record.
The listed secondary outcomes do not have detailed posted analyses in the record. Safety counts lack event terms, timing, causal attribution, and a stated comparative method. The primary timeframe is described as 6 months (enrollment to study completion), but the record does not provide individual follow-up durations or additional information about outcome ascertainment. These limitations constrain the conclusions that can be drawn from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease — NCT03141905.
- Registry record last updated 2021-04-14; status last verified 2021-03.
- Results first posted 2021-04-14.
- 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.
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18. Record Summary
NCT03141905 is a completed randomized, parallel-group study sponsored by University of Maryland, Baltimore. It enrolled 342 participants and compared a Sick-Day Protocol with usual care. The intervention included instructions for holding and resuming certain medicines during dehydrating illness and weekly remote monitoring. The primary outcome was change in renal function measured by creatinine, with results reported for 280 participants with complete laboratory data.
The posted median changes were 0.01 mg/dL for the Sick-Day Protocol arm and 0.02 mg/dL for usual care, each with a 95% confidence interval. The registry record does not report a direct between-arm estimate or statistical test. It also lists acute kidney injury incidents and emergency room use and hospitalization as secondary outcomes. Serious adverse events affecting participants were recorded as zero in both arms; other adverse events and deaths were also listed. Analysis details, missing-data methods, and multiplicity procedures are not reported in the registry record.