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 Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis (NCT00108355), a randomized phase 4 study. The primary outcome is Time to Recurrence of Ascites..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00108355 |
| Phase | Phase 4 |
| Condition | Ascites, Cirrhosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 29 |
| Arms in the primary outcome | 2 |
| Lead sponsor | US Department of Veterans Affairs |
| Results posted | Yes |
2. Clinical Question
The clinical question concerns what happens after large-volume paracentesis in people with cirrhosis and ascites: how does time to recurrence of ascites compare between an albumin regimen and a regimen combining Octreotide LAR and Midodrine? The registry record describes a randomized, parallel-group comparison. Its primary endpoint is time to recurrence of ascites, and its reported between-group analysis uses a log-rank test.
Population
People with cirrhosis and ascites undergoing large-volume paracentesis. The record lists enrollment of 29 participants; the primary-outcome arm counts are 13 in the Albumin group and 12 in the Vasoconstrictor group.
Intervention
After paracentesis, the study group received Octreotide LAR 20 mg by intramuscular injection every 30 days, Midodrine 10 mg by tablet three times a day, and a one-time intravenous saline infusion as the albumin placebo.
Comparator
After paracentesis, the control group received intravenous albumin at 25%, at 8 g/liter of ascitic fluid removed as a one-time dose, along with placebo injections and tablets.
Primary question
What is the time to recurrence of ascites in each group, and is there evidence of a difference in the time-to-event distributions? The registry reports medians and a log-rank comparison.
This question is about the comparative timing of recurrence in the studied groups. It is distinct from whether either regimen changes other clinical outcomes. The record lists development of post-paracentesis circulatory dysfunction as a secondary outcome, but a result for that outcome is not reported in the registry record. The comparison also does not, by itself, establish how the findings apply beyond the participants and treatment circumstances recorded for this trial.
3. Trial Design
The record describes a Phase 4, randomized, open-label, parallel-group trial sponsored by the US Department of Veterans Affairs. The listed conditions are ascites and cirrhosis. The brief summary states that the comparison was between Octreotide LAR plus Midodrine and albumin after large-volume paracentesis. Enrollment is listed as 29. The start is recorded as 2003-12, primary completion as 2010-08, and status as completed.
Participants in the albumin control group received intravenous albumin at 25%, dosed at 8 g/liter of ascitic fluid removed as a one-time dose. The group also received an intramuscular saline injection as an Octreotide LAR placebo every 30 days and an oral tablet as a Midodrine placebo three times a day. Participants in the vasoconstrictor study group received Octreotide LAR 20 mg by intramuscular injection every 30 days and Midodrine 10 mg three times a day, with a one-time intravenous saline infusion as the albumin placebo. Both regimens are described as occurring after paracentesis.
Masking is listed as none. That means the record does not describe the trial as blinded; the method used to generate the random allocation sequence and any allocation-concealment procedures are not reported in the registry record. The primary outcome is time to recurrence of ascites. The registry gives arm-specific counts for that outcome of 13 and 12, respectively. Those counts do not account for all 29 enrolled participants, and the reason for the difference is not reported in the registry record. The record lists two outcome measures and one analysis. It does not report the analysis population definitions or a detailed account of follow-up procedures.
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 | Albumin (Control Group) | Vasoconstrictors (Study Group) |
|---|---|---|
| STARTED | 15 | 14 |
| COMPLETED | 13 | 12 |
| NOT COMPLETED | 2 | 2 |
Reasons for not completing this period:
| Reason | Albumin (Control Group) | Vasoconstrictors (Study Group) |
|---|---|---|
| Peritonitis at index paracentesis | 1 | 1 |
| Loculated ascites, limiting paracentesis | 1 | 1 |
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 | Albumin (Control Group) | Vasoconstrictor (Treatment Group) | Total |
|---|---|---|---|---|
| Participants analysed | 13 | 12 | 25 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 11 | 10 | 21 |
| Age, Categorical: >=65 years | Participants | 2 | 2 | 4 |
| Age, Continuous: age median | years | 55 (inter quartile range 7.5) | 60 (inter quartile range 8.4) | 58 (inter quartile range 8) |
| Sex: Female, Male: Female | Participants | 3 | 0 | 3 |
| Sex: Female, Male: Male | Participants | 10 | 12 | 22 |
| Region of Enrollment: United States | participants | 13 | 12 | 25 |
6. Primary Endpoint
The registry lists the primary outcome as Time to Recurrence of Ascites., measured over Variable depending on the patient, average 10 days.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | days |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is time to recurrence of ascites, measured in days. A time-to-event endpoint records how long it takes for a specified event to occur. In this trial, the event is recurrence of ascites after large-volume paracentesis. The registry describes the timeframe as variable depending on the patient, with an average of 10 days.
Time-to-event measures are useful when the timing of an event matters and participants may have different follow-up durations. In general, such analyses can use information about event timing and account for participants whose event time is not observed during follow-up, if the analysis and data support that approach. The registry record does not describe censoring rules or how incomplete follow-up was handled, so those details cannot be assessed for this trial.
The registry reports the endpoint using the median and inter-quartile range. The median is the point at which half of the observed event times are at or below it and half are at or above it. The inter-quartile range describes the middle half of the observed values, with its lower and upper limits reported separately. In the Albumin group, the median is 10 days, with an inter-quartile range from 7 to 29 days. In the Vasoconstrictor group, the median is 8 days, with an inter-quartile range from 6 to 22 days.
These summaries describe the observed time-to-recurrence data; they are not, on their own, a complete estimate of the difference between groups. The record's formal comparison is a log-rank test.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports a median time to recurrence of ascites of 10 days in the Albumin group and 8 days in the Vasoconstrictor group. The inter-quartile ranges are 7 to 29 days and 6 to 22 days, respectively. These descriptive summaries indicate that the reported median is lower in the Vasoconstrictor group. They do not alone quantify the difference between the full time-to-event distributions, and they should not be read as a treatment effect estimate.
The reported comparison is a log-rank test, with p < 0.05. This is the registry's inferential result for the comparison of the groups' time-to-event data. In general, a p-value describes how compatible the observed data are with a specified null model, under the assumptions of the analysis. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. The record does not provide a hazard ratio or a numerical confidence interval for this comparison. It therefore does not give a registry-reported estimate of the relative event rate or a confidence interval that would show the precision of such an estimate.
The two arm-specific outcome counts are 13 and 12, while total enrollment is 29. The reason the primary-outcome counts do not include every enrolled participant is not reported in the registry record. The record also does not state whether those counts represent all randomized participants, participants with observed outcomes, or another analysis population. This limits interpretation of how fully the reported summaries represent the enrolled trial population.
The registry identifies development of post-paracentesis circulatory dysfunction as a secondary outcome, but its result is not reported in the registry record. No conclusion about that secondary outcome can be drawn from the primary endpoint summary. Likewise, the record does not provide enough information to assess follow-up completeness, censoring, or the effect of missing outcome data.
The statistical evidence should therefore be read narrowly: the registry reports a log-rank p-value below 0.05 for the between-group time-to-event comparison, alongside the stated medians and inter-quartile ranges. It does not report the size of a relative effect, its confidence interval, or enough analysis details to independently assess the assumptions and handling of incomplete data. These limitations do not negate the reported test, but they restrict the conclusions that can be drawn from the registry entry.
9. Statistical Methods Explained
The primary outcome is time to recurrence of ascites, and the registry reports a log-rank test comparing the Albumin and Vasoconstrictor groups. This is a time-to-event analysis: the relevant outcome is not simply whether recurrence happened, but when it happened after paracentesis. The registry also gives a median and inter-quartile range for each group.
What does the log-rank test compare?
General explanation: the log-rank test compares the event experience of groups over follow-up. It uses the ordering of event times to assess whether the observed time-to-event patterns differ, rather than comparing only the two reported medians. Its result is a test of evidence against a null hypothesis of no difference in the event distributions. The registry reports p < 0.05, but does not report the test statistic or further implementation details.
The log-rank test is commonly used when the endpoint is time until an event. General explanation: time-to-event data may include participants whose event is not observed during the available follow-up. Such observations are often described as censored. Valid interpretation depends on how follow-up and censoring are handled, among other design and analysis features. The registry record does not report the censoring rules, the numbers censored, or the method used to address incomplete follow-up. It is therefore not possible to determine from the registry entry how those issues affected this result.
What do the median and inter-quartile range convey?
The reported median is a summary of the event-time distribution. In the Albumin group, it is 10 days, with an inter-quartile range from 7 to 29 days. In the Vasoconstrictor group, it is 8 days, with an inter-quartile range from 6 to 22 days. General explanation: the inter-quartile range gives the interval between the lower and upper quartiles and describes the spread of the middle half of the observed values. It is not a confidence interval for the median, and the registry does not report confidence intervals for the medians.
A median comparison and a log-rank test answer related but different questions. The medians summarize a point in each group's distribution, while the log-rank test evaluates evidence about the time-to-event patterns across follow-up. Differences between medians alone do not establish the result of the log-rank test or indicate its precision. Conversely, the reported p-value does not describe the size of a difference. A hazard ratio or another effect estimate with a confidence interval could provide complementary information, but neither is reported for this comparison.
How should the p-value be read?
General explanation: a p-value measures the compatibility of observed data with a specified null model, assuming that model and the analysis assumptions apply. A smaller p-value indicates that the observed data would be less expected under that null model. It does not state the probability that the null is true, and it is not a measure of the probability that a treatment works. Here the reported value is p < 0.05. The record does not give an exact p-value beyond that threshold or detail the test's assumptions and implementation.
The record indicates a 95% confidence level for the reported analysis but provides no confidence-interval bounds. A confidence interval, in general, gives a range of values compatible with an estimate under a specified method and reflects statistical uncertainty. Without a reported estimate and interval bounds, the precision of a comparative effect cannot be assessed from that information.
Can the comparison be recalculated from the posted summaries?
No simple unadjusted recalculation is reported for this endpoint. The registry record identifies the endpoint as median time and specifies that values are missing or not estimable for a two-arm comparison of this type. The arm-specific medians and inter-quartile ranges are not sufficient to reconstruct the log-rank test or a hazard ratio. The registry's reported log-rank result is therefore the available formal comparison.
The record does not report a statistical analysis plan, any interim analyses, a sample-size justification, or detailed handling of missing data. Their absence from the registry entry does not establish whether such procedures existed elsewhere; it means they cannot be evaluated from this record. Any planning illustrations based on an observed effect are design calculations, not evidence of observed power, and do not substitute for the trial's own sample-size rationale.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Log Rank | not reported | < 0.050 |
The registry reports the sponsor's comparison as a log-rank test with p < 0.05. It also reports group-specific medians and inter-quartile ranges: 10 days, with an inter-quartile range from 7 to 29 days, for Albumin; and 8 days, with an inter-quartile range from 6 to 22 days, for Vasoconstrictor. The record lists a 95% confidence level for the analysis but does not provide confidence-interval bounds or a hazard ratio.
A separate simple recalculation is not estimable from the posted summary statistics for this median-time endpoint. In particular, the group medians and inter-quartile ranges do not contain the event-time information needed to reproduce a log-rank test. The sponsor's reported analysis is therefore the available formal comparison, rather than a result that can be independently recreated from those summaries.
The reported p-value supports a statement about the result of that test under its assumptions, not an estimate of the magnitude or precision of a comparative effect. Since no numerical effect estimate or interval bounds are reported, the registry record does not establish how large a difference the test reflects or how uncertain that magnitude is. The reason the outcome counts are 13 and 12 despite enrollment of 29 is also not reported in the registry record.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and identifies time to recurrence of ascites as the primary outcome. It also lists development of post-paracentesis circulatory dysfunction as a secondary outcome. A result for that secondary outcome is not reported in the registry record. The record reports one analysis, the log-rank comparison for the primary outcome.
Multiplicity refers generally to the interpretive issue that arises when several outcomes, time points, subgroups, or statistical tests are examined. When multiple tests are performed, the chance of at least one apparently notable result can increase unless the analysis plan accounts for that multiplicity. The registry record does not report a multiplicity adjustment, a hierarchy among outcomes beyond the primary designation, or a complete analysis plan. It is therefore not possible to assess how multiple outcomes or analyses were handled.
The primary-outcome arm counts are 13 for Albumin and 12 for Vasoconstrictor, while total enrollment is 29. Why the endpoint counts differ from total enrollment is not reported in the registry record. The registry does not specify an intention-to-treat population, a per-protocol population, or another analysis population, nor does it explain whether all randomized participants were included in the log-rank test.
Missing-data methods and follow-up completeness are not reported in the registry record. The record does not state how participants without an observed recurrence during follow-up were treated, whether censoring occurred, or how withdrawals or other incomplete observations were handled. Those details matter for time-to-event analysis because the amount and pattern of follow-up can influence the information contributing to a comparison.
These omissions do not establish that a particular analysis procedure was or was not used. They mean that the registry entry does not permit a reader to evaluate the planned multiplicity approach, analysis population, or missing-data assumptions. The reported p-value should be interpreted as the registry's reported result, with those reporting limitations in mind.
12. 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 |
|---|---|---|---|
| Albumin (Control Group) | 0 | 13 | 0.0% |
| Vasoconstrictor (Treatment Group) | 0 | 12 | 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 |
|---|---|
| Albumin (Control Group) | 3 of 13 |
| Vasoconstrictor (Treatment Group) | 4 of 12 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Albumin (Control Group) | Vasoconstrictor (Treatment Group) |
|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | 0 of 13 | 2 of 12 |
| Scrotal edema | Renal and urinary disorders | 1 of 13 | 1 of 12 |
| GI Bleeding | Gastrointestinal disorders | 1 of 13 | 0 of 12 |
| Hepatic encephalopathy | Hepatobiliary disorders | 1 of 13 | 0 of 12 |
| Pruritis | Skin and subcutaneous tissue disorders | 0 of 13 | 1 of 12 |
The registry reports zero serious adverse events among 13 participants at risk in the Albumin group and zero among 12 at risk in the Vasoconstrictor group. It separately reports other adverse events for 3 of 13 at risk in the Albumin group and 4 of 12 at risk in the Vasoconstrictor group. Death counts are not reported in the registry record.
These counts describe the entries recorded for the trial; they do not show whether an adverse event was judged related to a study regimen. The record does not provide the event terms, severity definitions, exposure-adjusted rates, timing, or further details for the reported non-serious events. The serious adverse event terms list is empty, so specific serious-event descriptions are not reported in the registry record.
Zero recorded serious adverse events in these groups should not be interpreted as proof that serious events could not occur. General explanation: safety summaries depend on the number of participants observed, the length and completeness of follow-up, definitions, and how events are collected and classified. Those details are not reported in the registry record. The counts are best read as the registry's reported events and denominators, not as a complete characterization of comparative safety.
13. What the Result Does, and Does Not, Mean
The posted results describe a randomized comparison after large-volume paracentesis in people with cirrhosis and ascites. For time to recurrence of ascites, the reported median is 10 days in the Albumin group and 8 days in the Vasoconstrictor group. The log-rank comparison is reported as p < 0.05. This identifies the registry's statistical result for the time-to-event comparison; it does not by itself describe the magnitude or precision of a difference.
The record does not provide a hazard ratio or confidence-interval bounds. Consequently, the relative event rate and the uncertainty around a numerical comparative estimate cannot be read from this entry. The medians and inter-quartile ranges summarize the observed group data but do not replace an effect estimate. The available endpoint counts are 13 and 12, and the reason they do not account for the total enrollment of 29 is not reported in the registry record.
The result does not establish what happened for the secondary outcome of post-paracentesis circulatory dysfunction, because its result is not reported in the registry record. Nor do the adverse-event counts give a full safety comparison: detail on event types and follow-up is limited, and deaths are not reported in the registry record.
General explanation: a randomized comparison can help assess differences between assigned groups, but conclusions depend on how randomization was carried out, how outcomes were measured, how missing observations were handled, and which participants entered the analysis. The registry identifies randomization and no masking, but does not report the randomization procedure, analysis population, or missing-data methods. These absences constrain interpretation and do not establish that a particular method was or was not used.
The result should therefore be understood as a reported log-rank finding in this trial, accompanied by the stated descriptive summaries. It is not, by itself, a complete account of effect size, precision, secondary outcomes, or applicability to people outside the recorded trial population.
14. Why This Trial Matters Statistically
This trial illustrates why time-to-event outcomes need more than a comparison of two medians. The primary endpoint concerns when ascites recurred, and the registry reports both group-specific median times and a log-rank test. The medians offer an accessible description of each group, while the log-rank test addresses the broader event-time patterns. Neither should be mistaken for a numerical estimate of the size of a treatment difference.
It also highlights the importance of reporting effect estimates and their uncertainty. The registry gives p < 0.05, but no hazard ratio or confidence-interval bounds. A p-value can indicate evidence against a null model under the test assumptions, but it cannot convey the magnitude or precision of an effect. The absence of those quantities makes it difficult to judge how much the time-to-event distributions differ and how precisely that difference is estimated.
The discrepancy between total enrollment of 29 and primary-outcome counts of 13 and 12 is another useful reporting issue. Without an explanation of the analysis population or missing observations, readers cannot determine why the endpoint counts differ from enrollment. This is particularly relevant for time-to-event outcomes, where follow-up and censoring affect interpretation.
Finally, the registry lists a secondary outcome and adverse-event counts, but provides limited results and detail for those areas. Together, these features show how a registry entry can convey a trial's central comparison while leaving questions about analysis methods, completeness, and interpretation unresolved. Reading statistical results well involves attending both to the reported test and to what is not documented.
15. 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 offers limited detail for independently evaluating the primary analysis. It reports a log-rank test and p < 0.05, but not the test statistic, a hazard ratio, or confidence-interval bounds. The arm-level medians and inter-quartile ranges cannot reconstruct the test or provide a comparative effect estimate.
Enrollment is listed as 29, whereas the primary-outcome counts are 13 in the Albumin group and 12 in the Vasoconstrictor group. The reason for this difference is not reported in the registry record. The analysis population, the number of participants with complete follow-up, and the handling of participants without a recorded recurrence are also not reported. This makes it difficult to assess how representative the outcome summaries are of those enrolled.
The record identifies the trial as randomized and open-label, but the sequence-generation method and allocation-concealment procedures are not reported. It does not report whether outcome assessment was blinded, or whether that was feasible for this endpoint. Detailed eligibility criteria and participant characteristics are not included in the listed details, limiting assessment of how closely the trial population aligns with other populations.
The registry names post-paracentesis circulatory dysfunction as a secondary outcome but does not report its result. Adverse-event information is limited to group counts; event terms, timing, and attribution are not reported, and deaths are not reported in the registry record. The record also does not describe a statistical analysis plan, sample-size justification, interim analyses, or multiplicity procedures. These are limitations of the registry reporting and do not establish whether such details were documented elsewhere.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis — NCT00108355.
- Registry record last updated 2014-03-06; status last verified 2014-02.
- Results first posted 2014-03-06.
- 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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19. Record Summary
The registry describes a completed, Phase 4, randomized, open-label, parallel-group trial sponsored by the US Department of Veterans Affairs. It compares albumin with Octreotide LAR plus Midodrine after large-volume paracentesis in people with cirrhosis and ascites. Enrollment is listed as 29.
The primary endpoint is time to recurrence of ascites. The reported medians are 10 days for Albumin and 8 days for Vasoconstrictor, with inter-quartile ranges from 7 to 29 days and from 6 to 22 days, respectively. The registry reports a log-rank test with p < 0.05. A hazard ratio and confidence-interval bounds are not reported.
The record lists post-paracentesis circulatory dysfunction as a secondary outcome but does not report its result. It reports zero serious adverse events in each group and other adverse events for 3 of 13 and 4 of 12 participants at risk; deaths are not reported in the registry record. The reasons for the primary-outcome counts and the details of missing-data handling are not reported in the registry record.