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 A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis (NCT02528097), a randomized na study. The primary outcome is Renal Failure.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02528097 |
| Phase | NA |
| Condition | Spontaneous Bacterial Peritonitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 2 |
| Arms in the primary outcome | n/a |
| Lead sponsor | NYU Langone Health |
| Results posted | Yes |
2. Clinical Question
Population
People with spontaneous bacterial peritonitis were the intended population. The registry record gives no further eligibility details or description of participant characteristics. Although enrollment is recorded as 2, outcome data were not collected because of logistical challenges.
Intervention
The experimental schedule began with albumin on day 1 at 1.5g/kg. A second dose on day 2 was intended only for people with renal insufficiency and risk for renal failure, with the description referring to Cr > 1.0 or BUN or Cr > baseline. Further details of the experimental schedule are not reported in the registry record.
Comparator
The active comparator was standard care: albumin on day 1 at 1.5g/kg and on day 3 at 1.0g/kg. Both groups were described as receiving albumin on day 1; the timing and eligibility for the second dose distinguished the schedules.
Primary question
The intended question was whether giving the second dose at 48 hours only to people meeting renal-risk criteria could prevent renal failure as effectively as giving the second dose to all participants at 72 hours. Renal failure was to be assessed from time 0 through day 3. Because outcome data were not collected, the registry record does not answer this comparison.
3. Trial Design
The registry record describes a randomized, parallel-group trial with no masking. It lists spontaneous bacterial peritonitis as the condition and NYU Langone Health as the sponsor. The recorded enrollment is 2. The study is marked terminated; the recorded start is 2010-09 and the primary completion is 2015-01. The phase is listed as NA.
The two groups were intended to differ in the timing and use of the second albumin dose. Standard care specified albumin on day 1 at 1.5g/kg and day 3 at 1.0g/kg. The experimental schedule specified albumin on day 1 at 1.5g/kg, with the second dose on day 2 only for people meeting renal-insufficiency and renal-risk criteria. The registry description also mentions daily BUN and Cr monitoring for 72 hours if albumin was not administered at 48 hours, but the remaining monitoring description is not reported in the registry record.
Randomization is the stated allocation approach, but the sequence-generation method, allocation concealment, and any stratification are not reported in the registry record. The record identifies no masking, so the comparison was not blinded according to that entry. It does not explain how treatment assignment or adherence was monitored. Most importantly for interpreting the design, it states that outcome data were not collected because of logistical challenges. Thus, although the intended groups and primary outcome are described, the record does not contain a completed outcome comparison.
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 | Active Comparator Standard Care | Experimental |
|---|---|---|
| STARTED | 1 | 1 |
| COMPLETED | 1 | 1 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Outcome data was not collected due to logistical challenges of completing the study.
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 | Active Comparator Standard Care | Experimental | Total |
|---|---|---|---|---|
| Participants analysed | 1 | 1 | 2 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | 1 | 2 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 0 | 1 | 1 |
| Sex: Female, Male: Male | Participants | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Renal Failure, measured over At any point from time 0 through day 3.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was renal failure occurring at any point from time 0 through day 3, also described as the period through 72 hours. It was intended to capture whether renal failure arose during the early period after study start, rather than to measure only renal status at a single final assessment. The registry record does not give a detailed operational definition of renal failure, threshold criteria, or procedures for confirming an event; those details are not reported in the registry record.
As a general statistical concept, an endpoint should translate the trial’s question into an outcome that can be consistently observed and compared between assigned groups. A time-window endpoint can include events occurring at different moments within that window, but interpreting it depends on clear event criteria and complete ascertainment. In this trial, the stated endpoint matches the intended question about preventing early renal failure under different albumin schedules. However, the registry record explicitly says outcome data were not collected because of logistical challenges. There are therefore no posted renal-failure counts or group estimates with which to assess the endpoint or compare the schedules.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the registry record reports no collected outcome data for the primary endpoint. It therefore provides no observed comparison of renal failure between standard care and the experimental albumin schedule. No group-specific renal-failure counts, effect estimate, confidence interval, or p-value are reported in the registry record. The planned comparison cannot be treated as a finding about whether either schedule changed renal-failure occurrence.
The record identifies all-cause mortality as a secondary outcome, but no mortality result is reported. The safety entries show 0 serious adverse events among 1 participant at risk in each group and 0 other adverse events among 1 participant at risk in each group. These counts do not substitute for the missing renal-failure outcome, and the small number of participants represented by the safety entries limits what can be inferred from them. Death counts are not reported in the registry record.
The trial’s stated rationale was to examine whether a kidney-function-guided second dose could be as effective as a second dose for all participants, while potentially reducing albumin use and costs. That rationale describes the question motivating the comparison; it is not a result. The registry record does not report a renal-failure comparison or a cost or resource-use result. It also does not provide a completed statistical analysis, with the number of analyses recorded as 0.
Random allocation would ordinarily support a comparison between assigned groups if outcomes were collected and analyzed appropriately. Here, however, the lack of outcome data means that randomization cannot yield an estimate of the treatment contrast. The recorded enrollment of 2 should not be mistaken for evidence about efficacy or for a basis to infer what would have happened under either schedule. The posted information supports a description of the intended design and the reason given for missing outcomes, not a conclusion about the primary question.
In general, a confidence interval describes the range of effect values compatible with an estimate under a specified statistical model. No confidence interval is reported for renal failure, because the registry record contains no outcome comparison. Accordingly, there is no reported precision estimate for the primary question. The uncertainty is not simply a wide interval around a small effect; rather, the comparison itself is unavailable in the posted results.
9. Statistical Methods Explained
What does randomization contribute?
In general, randomization assigns participants to groups using a chance-based process. If allocation is implemented as intended and outcomes are collected, it can help make groups comparable with respect to both measured and unmeasured characteristics at the start of a trial. This supports interpreting later differences as associated with the assigned schedules, subject to the trial’s conduct, outcome measurement, and analysis.
The registry record states that allocation was randomized and that the trial used a parallel model. It does not report how the random sequence was generated, whether assignment was concealed before enrollment, or whether randomization was stratified. These details are not reported in the registry record, so the specific safeguards around assignment cannot be assessed from the posted information. Randomization alone also does not ensure that outcomes are complete or that an estimate can be calculated.
Why does the missing outcome data matter?
The planned primary outcome was the presence of renal failure at any point from time 0 through day 3. To compare groups, the trial would need ascertainment of that endpoint for participants, followed by an analysis that relates outcomes to treatment assignment. The registry record states that outcome data were not collected because of logistical challenges. Consequently, no primary-outcome contrast is available to interpret, and no standard error, confidence interval, or significance test for that contrast is reported.
In general, missing outcome data can create uncertainty about both the amount and the direction of a treatment effect. The implications depend on why data are missing, which participants are affected, and whether missingness is related to treatment or outcome. The registry record gives a logistical explanation but does not describe the specific data-collection failures, whether any partial outcome information existed, or whether a missing-data analysis was conducted. Such details are not reported in the registry record. With no recorded outcome data, a statistical adjustment cannot recover an observed treatment comparison from the posted record.
What would an effect estimate and interval mean?
In general, an effect estimate summarizes the contrast between groups on an outcome, while its confidence interval conveys statistical uncertainty about that estimate under the analysis assumptions. A p-value, when reported, addresses compatibility between the observed data and a specified null hypothesis; it is not a measure of clinical importance or the probability that a treatment works. These statistics require outcome information and a defined analysis. None is reported for renal failure in the registry record.
It is also useful to distinguish lack of a reported estimate from evidence that the groups were equivalent. Equivalence or noninferiority requires a suitable design and a prespecified margin, among other elements. The registry description expresses an interest in whether the experimental schedule is as effective as standard care, but the record does not report a margin or an outcome analysis. Therefore, the intended wording of the question cannot be taken as a demonstrated equivalence result.
How should the sample-size illustrations be understood?
In general, a sample-size calculation is a planning exercise based on assumptions about the target effect, variability, significance level, allocation, and analysis. It does not describe the number of participants actually studied, and it is not an observed treatment result. The registry record’s stated illustration assumptions use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of the observed effect. It also distinguishes participant counts per arm for non-time-to-event outcomes from total event counts for time-to-event calculations.
Those assumptions do not establish that the trial itself was designed using that calculation. A protocol-based sample-size justification, its target effect, and the basis for its assumptions are not reported in the registry record. Nor does a planning illustration establish observed power. Since the primary outcome data were not collected, the record does not provide a renal-failure effect estimate that could be interpreted as the trial’s observed result. Any planning illustration should therefore be read as a hypothetical calculation under its stated assumptions, not as evidence about the comparison.
What can be inferred from the recorded analyses?
The registry record lists 0 analyses. It does not report a primary statistical model, a method for handling the primary endpoint, an analysis population, or a strategy for missing data. These details are not reported in the registry record. In general, analysis choices matter because they determine how outcomes are summarized, how participants are handled after randomization, and what uncertainty statements mean. In this case, the absence of outcome data and analysis entries prevents assessment of the intended comparison through a completed statistical analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry record names renal failure as the primary outcome and all-cause mortality as a secondary outcome. It also records 3 outcome measures, but the details of any additional measures are not reported in the registry record. The number of analyses is recorded as 0. No outcome-specific analysis plan, hierarchy of hypotheses, or multiplicity adjustment is reported in the registry record.
As a general statistical concept, multiplicity arises when several outcomes, time points, subgroups, or statistical tests are examined. Without a prespecified strategy, repeated testing can increase the chance of findings that appear noteworthy by chance. A hierarchy or adjustment can help define how multiple questions are interpreted. The registry record does not report such procedures, so multiplicity handling cannot be assessed.
The primary endpoint has a stated window from time 0 through day 3, but the record does not describe a statistical method for handling the timing of events within that window. It also does not report an analysis population, such as whether analyses were intended to follow randomized assignment or treatment received. These details are not reported in the registry record.
The stated reason for the absence of primary outcome data is logistical challenges in completing the study. The record does not specify which observations were unavailable, whether mortality was ascertained, or whether any missing-data procedures were attempted. Those details are not reported in the registry record. Because outcome data were not collected, the central issue is not merely how a statistical method handled some missing observations: no renal-failure comparison is posted.
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 |
|---|---|---|---|
| Active Comparator Standard Care | 0 | 1 | 0.0% |
| Experimental | 0 | 1 | 0.0% |
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 |
|---|---|
| Active Comparator Standard Care | 0 of 1 |
| Experimental | 0 of 1 |
The safety entries report 0 serious adverse events among 1 participant at risk in the standard-care group and 0 among 1 participant at risk in the experimental group. For other adverse events, the record reports 0 affected among 1 at risk in each group. These are the posted counts; they should be read alongside the recorded number at risk and not as a broad safety conclusion.
In general, an adverse-event count describes events captured under the trial’s reporting and observation procedures. A zero count in a small group does not establish that an event cannot occur, and it does not quantify comparative safety with precision. The registry record does not describe the adverse-event collection period or detailed ascertainment procedures. Death counts are null and therefore are not reported in the registry record. All-cause mortality is listed as a secondary outcome, but a mortality result is not reported. These safety entries do not provide information about the missing renal-failure endpoint.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, parallel-group comparison of two albumin schedules was intended for spontaneous bacterial peritonitis. The primary question concerned renal failure through 72 hours, with a second dose planned at different times and under different eligibility conditions in the two groups. The record also gives a reason for the lack of outcome results: outcome data were not collected because of logistical challenges.
It does not establish whether the experimental schedule prevented renal failure as effectively as standard care. There are no reported group outcome counts, effect estimates, confidence intervals, or p-values for the primary endpoint. The registry entry’s statement of the hypothesis is not evidence that the hypothesis was supported. The listed mortality outcome and the safety counts likewise do not resolve the primary question.
The record also cannot establish whether the experimental schedule reduced albumin use, costs, or resource use. Those potential advantages appear in the study rationale, but no corresponding results are reported in the registry record. Any claim about efficacy, equivalence, safety, or resource savings would go beyond the posted results.
More generally, a trial’s planned comparison and its observed evidence are distinct. The intended design describes what researchers meant to compare; collected outcomes and an appropriate analysis are needed to estimate what happened. Here, the posted information supports understanding the intended comparison and its limitations, but it does not support a treatment-effect conclusion.
13. Why This Trial Matters Statistically
This trial is statistically notable because it illustrates the difference between a randomized design and an informative randomized comparison. Random allocation is an important design feature, but it cannot produce an estimate when the outcome is not collected. The record states that outcome data were unavailable because of logistical challenges, leaving the planned renal-failure comparison unanswered.
The study also frames a practical strategy question: whether a second albumin dose guided by renal-risk criteria might be compared with a schedule giving the second dose to all participants. Such a question involves both a clinical endpoint and a proposed resource-use rationale. Statistical evaluation would need outcome data for renal failure and, to assess the resource rationale, relevant measurements of albumin use or costs. Those results are not reported in the registry record.
For readers, the key lesson is to separate design intent from results. A stated hypothesis, a randomized allocation, and a defined endpoint do not by themselves demonstrate an effect. Estimates and uncertainty measures require analyzable outcomes. The record’s small recorded enrollment and missing outcome data further underscore why no treatment comparison can be inferred from the posted information. The value of the record is therefore in documenting the question and the incomplete outcome reporting, rather than in resolving the relative performance of the schedules.
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 main limitation is explicit: outcome data were not collected because of logistical challenges. Consequently, the primary outcome cannot be compared between groups, and the record does not report an effect estimate or its precision. The recorded enrollment is 2, so the posted participant count is also very limited; however, the absence of collected outcomes, rather than a particular statistical result, is the decisive constraint on interpretation.
The registry record does not report detailed eligibility criteria, participant characteristics, the random-sequence method, allocation concealment, or a protocol-based sample-size justification. It also does not provide a full operational definition of renal failure or detailed endpoint ascertainment procedures. These details are not reported in the registry record and limit assessment of how the intended comparison would have been implemented.
The experimental-arm description includes renal-risk criteria and a monitoring description, but the available description ends before all monitoring instructions are given. Further details are not reported in the registry record. The record does not describe adherence, treatment crossover, or the analysis population. It also does not report how missing data were characterized or whether any analyses were attempted to address their absence.
Finally, the registry lists all-cause mortality as a secondary outcome and records safety counts, but does not provide a mortality result or detailed safety-collection methods. No cost or resource-use results are reported. Together, these omissions mean the record cannot support conclusions about the primary endpoint, the secondary outcome, comparative safety, or the proposed resource implications.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis — NCT02528097.
- Registry record last updated 2016-07-11; status last verified 2016-05.
- Results first posted 2016-07-11.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a randomized, unmasked, parallel-group study sponsored by NYU Langone Health, with recorded enrollment of 2 and status listed as terminated. It compared standard albumin dosing on day 1 and day 3 with an experimental schedule using a second dose on day 2 only for people meeting renal-risk criteria. Renal failure from time 0 through day 3 was the primary outcome. The record states that outcome data were not collected because of logistical challenges, and it reports no primary-outcome comparison. All-cause mortality is listed as a secondary outcome without a reported result. Safety entries report 0 serious and 0 other adverse events among 1 participant at risk in each group; death counts are not reported in the registry record. The intended treatment comparison and its rationale are documented, but the posted results do not establish an effect on renal failure, mortality, safety, or resource use.