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 Comparative Evaluation of Albumin and Starch Effects in Acute Lung Injury (ALI) (NCT00796419), a randomized phase 3 study. The primary outcome is Change in Extravascular Lung Water (EVLW).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00796419 |
| Phase | Phase 3 |
| Condition | Lung Injury, Acute (ALI), Respiratory Distress Syndrome, Acute (ARDS) |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 31 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Emory University |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned patients with acute lung injury or acute respiratory distress syndrome and low blood protein levels. The registry describes the intended population in its summary; further eligibility details are not reported in the registry record. Enrollment was 31.
Intervention
The intervention was intravenous 5% human albumin. The trial sought to examine how therapies affecting blood proteins relate to lung and cardiovascular function, including measurements intended to characterize lung water and oxygenation.
Comparator
The comparator was intravenous 6% hetastarch. The registry lists both therapies as drug interventions and describes a randomized, parallel-group trial.
Primary question
The primary endpoint was change in extravascular lung water, measured in mL/kg from baseline to Day 5 (120 hours). The registry record does not report a numerical comparison of change between the treatment groups, so the posted information does not establish the direction or precision of a primary-outcome difference.
3. Trial Design
This was a Phase III randomized, quadruple-masked, parallel-group study sponsored by Emory University. The registry lists acute lung injury and acute respiratory distress syndrome as the conditions of interest. The enrollment was 31. The listed interventions were intravenous 5% human albumin and intravenous 6% hetastarch.
The record gives a start date of 2009-01 and a primary completion date of 2015-11. Its status is terminated. These registry entries describe the study’s administrative record; they do not, by themselves, explain why the study ended or establish what its results were. The reason for termination is not reported in the registry record.
Random allocation means that assignment was intended to use a chance-based process rather than being determined solely by clinical choice. Masking is intended to limit the influence of knowledge about assigned treatment on aspects of trial conduct or assessment. The record labels masking as quadruple, but does not specify which roles were masked or how masking was maintained. Those details are not reported in the registry record.
A parallel-group design assigns participants to a treatment group and compares outcomes between groups. The primary endpoint was a continuous measurement: change in extravascular lung water from baseline to Day 5 (120 hours). The registry describes the endpoint as a mean with standard deviation. It also lists change in the PaO2/FiO2 ratio and ventilator-free days as secondary outcomes. The posted record does not give numerical results for those outcomes or a detailed account of the analysis plan.
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.
Before assignment: Not all consented subjects were treated due to changes in eligibility between the consent and treatment periods or subject withdrawal from the study after consent but prior to treatment. 31 individuals gave consent to participate in the study, however, 4 did not begin the study intervention, resulting in 27 who started treatment.
Overall Study
| Stage | Intravenous 5% Human Albumin | Intravenous 6% Hetastarch |
|---|---|---|
| STARTED | 13 | 14 |
| COMPLETED | 13 | 13 |
| NOT COMPLETED | 0 | 1 |
Reasons for not completing this period:
| Reason | Intravenous 5% Human Albumin | Intravenous 6% Hetastarch |
|---|---|---|
| Death | 0 | 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 | Intravenous 5% Human Albumin | Intravenous 6% Hetastarch | Total |
|---|---|---|---|---|
| Participants analysed | 13 | 14 | 27 | |
| Age, Continuous | years | 49 (SD 16) | 50 (SD 16) | 49 (SD 15) |
| Sex: Female, Male: Female | Participants | 8 | 9 | 17 |
| Sex: Female, Male: Male | Participants | 5 | 5 | 10 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 0 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 11 | 14 | 25 |
| 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 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 4 | 9 | 13 |
| Race (NIH/OMB): White | Participants | 7 | 5 | 12 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 0 | 2 |
| Region of Enrollment: United States | participants | 13 | 14 | 31 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Extravascular Lung Water (EVLW), measured over Baseline to Day 5 (120 hours).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mL/kg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change in extravascular lung water (EVLW) from baseline to Day 5 (120 hours), measured in mL/kg. The registry says EVLW was measured by transpulmonary thermodilution. It describes the endpoint as a mean with standard deviation and states that higher EVLW per kilogram indicates increased lung injury. Normal values are thought to be less than 10 mL/kg.
EVLW is used as a physiological measure of water outside the blood vessels in the lungs. In general, a continuous measurement can capture degrees of change rather than only classifying participants into categories. Comparing change between randomized groups can therefore describe whether the groups’ measured trajectories differed during the specified period. The meaning of any estimated difference depends on the observed values, the variability of those values, and the uncertainty around the comparison.
The registry’s posted information does not give group means, standard deviations, a between-group estimate, or a confidence interval for this endpoint. It also does not provide a numerical direction or magnitude of change. The endpoint definition alone explains what was measured and why it was relevant to lung injury; it cannot substitute for the missing outcome results. The record notes that the primary outcome has several categories or time points and was not reduced to one comparison. More detail about how those categories or time points were handled is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically relevant physiological endpoint and two active fluid-related interventions, but it does not report a numerical primary-outcome comparison. Without group-level EVLW changes or an estimated between-group difference, the direction and magnitude of any contrast cannot be described. Without an uncertainty interval or a test result, the precision and statistical compatibility of the data with different possible effects also cannot be assessed from the posted record.
The record reports enrollment of 31 and marks the study as terminated. Those details are important context, but they do not establish why enrollment stopped, whether the planned enrollment was reached, or how termination affected the analysis. Such explanations are not reported in the registry record. Enrollment alone does not show how many participants contributed usable primary-outcome data at the specified measurement times.
The record lists change in oxygenation, measured by the PaO2/FiO2 ratio, and ventilator-free days as secondary outcomes. Numerical results for these outcomes are not reported in the registry record. The listed outcome names indicate what the trial intended to assess; they do not show whether the groups differed or how precisely any differences were estimated.
Safety information is posted separately. Serious adverse events were reported for 4 of 13 participants at risk in the albumin group and 5 of 14 participants at risk in the hetastarch group. Other adverse events were reported for 6 of 13 and 6 of 14 participants at risk, respectively. Deaths were listed as 1 and 3, respectively. These are descriptive counts, and the record does not provide a statistical comparison or uncertainty estimates for them. They should not be treated as evidence that one treatment caused or prevented an event.
In general, an estimate describes the observed contrast, while a confidence interval expresses the precision of that estimate and the range of values compatible with the analysis under its assumptions. Neither can be reconstructed for the primary endpoint from the details posted in the registry record. No sponsor analysis or numerical recalculation is available in the record to resolve that gap.
The trial record therefore supports a description of design, endpoint, and reported safety counts, but not a conclusion about the comparative primary-outcome result. A lack of posted numerical results is not evidence that the treatments had identical outcomes; it means that the comparison cannot be evaluated from the reported information.
9. Statistical Methods Explained
The statistical interpretation is limited by what the registry record reports. It identifies a randomized parallel-group study, a continuous primary endpoint, and descriptive safety counts. It does not provide the numerical primary-outcome results or a detailed statistical analysis plan. The concepts below are general explanations of how such methods are ordinarily interpreted; they are not claims about analyses performed in this trial.
What does randomization contribute?
In general, randomization uses chance to assign participants to treatment groups. This can reduce systematic differences between groups at the start of a study, including differences that are known and those not measured. Randomization does not guarantee that groups will be identical, particularly in a study with limited enrollment. It also cannot correct problems that occur after assignment, such as missing measurements, deviations from assigned treatment, or selective reporting. The registry states that allocation was randomized, but the sequence-generation and allocation-concealment procedures are not reported in the registry record.
How should a change endpoint be compared?
EVLW was measured at baseline and Day 5 (120 hours), and the stated endpoint is change over that interval. In general, an analysis may compare each group’s mean change or estimate the difference between groups in mean change. A between-group estimate is more informative for the randomized comparison than describing change in one group alone. The estimate should be interpreted with its uncertainty, usually expressed as a confidence interval. The record reports neither group means nor a between-group estimate or confidence interval, so none can be interpreted for this endpoint.
The registry specifies a mean and standard deviation. A mean describes the central average of a continuous measurement, while a standard deviation describes how spread out measurements are around that average. The standard deviation is not the same as the uncertainty in the estimated mean or the treatment contrast. A confidence interval for a contrast reflects sampling uncertainty under the analysis assumptions. No standard deviations or confidence intervals for the primary endpoint are reported in the registry record.
Why does the endpoint structure matter?
The record indicates that the primary outcome has several categories or time points and was not reduced to one comparison. In general, multiple outcome definitions or repeated measurements can require a clear plan for identifying the primary contrast. Different choices about time point, summary measure, or treatment of repeated observations can lead to different interpretations. The registry record does not explain the categories or time points in more detail, nor does it identify a single numerical primary comparison.
What is over-dispersion?
In general, over-dispersion occurs when observed variability is greater than a statistical model assumes. It matters because a model that understates variability can produce uncertainty estimates that are too narrow and tests that appear more decisive than warranted. This concept is particularly relevant to some count or binary-outcome models. The listed primary endpoint is continuous, and the registry does not report a model or an over-dispersion assessment. It would therefore be inappropriate to claim that over-dispersion was tested, present, or handled in this trial.
What do planning calculations mean?
In general, sample-size calculations are planning exercises based on assumptions about the effect to detect, variability, significance level, allocation, and statistical method. They do not show how many participants were actually analyzed and do not measure the observed study’s power. The record describes a planning illustration based on a fraction of the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. No numerical planning results are reported in the registry record. Such illustrations cannot replace an observed estimate or its uncertainty, and they are not evidence that the trial was designed around those assumptions.
Can a recalculation fill the gap?
In general, an unadjusted recalculation may be possible when the posted summary statistics needed for it are available. It would remain distinct from the sponsor’s prespecified analysis, which can account for design features or analysis choices not captured by a simple calculation. The registry record does not provide the primary-outcome summary statistics needed for a recalculation, nor does it report a sponsor analysis of that endpoint. No numerical recalculated result can therefore be interpreted from the record.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity concerns arise when a study assesses multiple outcomes, time points, or comparisons. In general, evaluating many possible contrasts can increase the chance that at least one appears unusual by chance. A statistical plan may designate a primary comparison in advance or use an approach that accounts for multiple testing. The registry lists a primary endpoint and secondary outcomes, but also states that the primary outcome has several categories or time points and was not reduced to one comparison. A multiplicity strategy is not reported in the registry record.
The record does not report a detailed analysis plan, including how the primary endpoint’s categories or time points were selected or combined. It also does not state whether secondary outcomes were treated as confirmatory or exploratory, or whether any adjustment for multiple comparisons was planned. These omissions prevent assessment of how the reported outcome structure would affect interpretation. They do not establish that a particular analysis method was or was not used.
Missing-data handling is also not reported in the registry record. The posted enrollment does not indicate the number of participants with outcome measurements at each time point. The registry record does not describe withdrawals, exclusions from analysis, reasons for missing measurements, or any method for handling missing values. In general, missingness can affect an estimate when the availability of measurements is related to participant characteristics or outcomes. The amount and pattern of missing data, and the assumptions used to address them, are needed to assess that risk.
The analysis population is not reported in the registry record. It is therefore unclear from the posted information whether the primary comparison was intended to include all randomized participants, participants with available measurements, or another defined group. The record lists no analyses. Without a stated analysis population, missing-data approach, and outcome results, the statistical interpretation remains limited to the design description and the descriptive safety counts.
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 |
|---|---|---|---|
| Intravenous 5% Human Albumin | 4 | 13 | 30.8% |
| Intravenous 6% Hetastarch | 5 | 14 | 35.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intravenous 5% Human Albumin | 1 of 13 |
| Intravenous 6% Hetastarch | 3 of 14 |
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 |
|---|---|
| Intravenous 5% Human Albumin | 6 of 13 |
| Intravenous 6% Hetastarch | 6 of 14 |
Most frequent serious adverse event terms
| Event term | Organ system | Intravenous 5% Human Albumin | Intravenous 6% Hetastarch |
|---|---|---|---|
| Death | General disorders | 1 of 13 | 3 of 14 |
| Shock | General disorders | 0 of 13 | 2 of 14 |
| Re-hospitalization | General disorders | 1 of 13 | 0 of 14 |
| Acute kidney injury | Renal and urinary disorders | 1 of 13 | 0 of 14 |
| Acute hepatic injury | Hepatobiliary disorders | 0 of 13 | 1 of 14 |
| Bleeding | General disorders | 0 of 13 | 1 of 14 |
| Cardiac arrest | Cardiac disorders | 0 of 13 | 1 of 14 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 0 of 13 | 1 of 14 |
| Focal weakness | General disorders | 0 of 13 | 1 of 14 |
| Acute respiratory distress/failure | Respiratory, thoracic and mediastinal disorders | 1 of 13 | 0 of 14 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Intravenous 5% Human Albumin | Intravenous 6% Hetastarch |
|---|---|---|---|
| Systemic hypotension | General disorders | 4 of 13 | 3 of 14 |
| Bleeding/coagulopathy | Blood and lymphatic system disorders | 0 of 13 | 4 of 14 |
| Worsening pulmonary edema or lung injury | Respiratory, thoracic and mediastinal disorders | 2 of 13 | 1 of 14 |
| Systemic hypertension | General disorders | 1 of 13 | 0 of 14 |
| Myocardial ischemia | Cardiac disorders | 0 of 13 | 1 of 14 |
| Increase in serum amylase or lipase | Blood and lymphatic system disorders | 0 of 13 | 1 of 14 |
| Secondary infection or sepsis | Infections and infestations | 0 of 13 | 1 of 14 |
| Pericardial effusion | Cardiac disorders | 1 of 13 | 0 of 14 |
| Tachycardia | Cardiac disorders | 1 of 13 | 0 of 14 |
Serious events with the highest arm-level rate: death (21.4%), shock (14.3%), re-hospitalization (7.7%), acute kidney injury (7.7%), acute respiratory distress/failure (7.7%).
The registry reports serious adverse events for 4 of 13 participants at risk in the intravenous 5% human albumin group and 5 of 14 participants at risk in the intravenous 6% hetastarch group. Other adverse events were reported for 6 of 13 and 6 of 14 participants at risk, respectively. Deaths were listed as 1 in the albumin group and 3 in the hetastarch group. These figures are descriptive registry counts, not estimates of a treatment effect.
The record also lists serious-event terms with percentages: Death, 21.4%; Shock, 14.3%; Re-hospitalization, 7.7%; Acute kidney injury, 7.7%; Acute respiratory distress/failure, 7.7%; and Acute hepatic injury, 7.1%. The denominator and counting rules for these percentages are not reported in the registry record. The terms should not be read as a complete ranking of all possible harms or as evidence that an intervention caused a particular event.
In general, adverse-event counts describe events recorded during a study, while a comparative safety assessment requires attention to event definitions, exposure, follow-up, and uncertainty. The registry does not report a statistical comparison or confidence intervals for these figures. Differences in the displayed counts alone cannot establish a reliable difference between groups or its cause.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, quadruple-masked, parallel-group Phase III trial compared intravenous 5% human albumin with intravenous 6% hetastarch in acute lung injury and acute respiratory distress syndrome. It identifies change in extravascular lung water from baseline to Day 5 (120 hours) as the primary endpoint and describes how that measurement was obtained. It also lists secondary outcomes and descriptive adverse-event counts.
It does not report a numerical result for the primary endpoint. In particular, there is no posted group mean, standard deviation, between-group estimate, confidence interval, or test result for EVLW change. The record therefore does not establish the direction, magnitude, or precision of a primary-outcome contrast. Results for change in oxygenation and ventilator-free days are also not reported in the registry record.
This absence should not be interpreted as proof of no difference. It also cannot support a claim that one treatment was better or worse. The registry record’s termination status and enrollment do not supply the missing outcome estimates or explain why the study ended. The reason for termination is not reported in the registry record.
The safety counts offer a limited descriptive account of serious and other adverse events, but no comparative analysis or uncertainty estimates are posted. Their interpretation depends on details such as event definitions, follow-up, and denominator rules, which are not fully reported. The counts alone do not show that an intervention caused an event or that a treatment prevented one.
In general, a clinical trial’s result is best interpreted through its estimated treatment contrast, the uncertainty around that estimate, the analysis population, and the way missing data and multiple outcomes were handled. Those elements are not available for the primary comparison in the registry record. The appropriate reading is therefore narrow: the record documents the study design and endpoint, but does not provide enough numerical outcome information to evaluate the comparative primary result.
13. Why This Trial Matters Statistically
This trial is statistically notable because it paired random assignment with a physiological endpoint intended to measure lung water over a defined period. Continuous outcomes can retain information about the degree of change, and a comparison of group changes can provide a focused estimate of a treatment contrast. That potential is realized only when the outcome values, the comparison, and its uncertainty are reported.
The registry record makes the endpoint and its measurement units clear, but does not report the numerical primary-outcome comparison. It also notes that the primary outcome has several categories or time points and was not reduced to one comparison. This underscores a general reporting issue: readers need to know which comparison represents the primary question when an outcome can be expressed in multiple ways. Without that information and the corresponding estimate, the endpoint definition cannot answer the comparative question.
The record also illustrates why trial design details and results have different roles. Randomization and masking describe safeguards intended to support an interpretable comparison. Enrollment, completion information, and status describe the study’s conduct at a broad level. None of these details replaces an effect estimate with an account of its precision. Similarly, descriptive safety counts are useful context but do not substitute for a planned comparative safety analysis.
For biostatisticians and clinical researchers, the record highlights the importance of reporting the analysis population, missing-data methods, multiplicity strategy, and outcome estimates alongside the trial design. Those details are not reported in the registry record. Their absence limits what can be learned from the posted results, regardless of the endpoint’s clinical relevance or the study’s randomized design.
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 central limitation for interpreting this trial is that the registry record does not report numerical results for the primary endpoint. Without group-level EVLW changes or a between-group estimate and uncertainty interval, the primary comparison cannot be evaluated. The record’s note that the outcome has several categories or time points and was not reduced to one comparison adds uncertainty about which contrast would represent the main result.
The registry does not report the detailed statistical analysis plan, the analysis population, or the handling of missing outcome measurements. It also does not describe the randomization procedure, allocation concealment, or the roles covered by quadruple masking. These details are not reported in the registry record, so their implementation cannot be assessed.
Enrollment was 31 and the study status is terminated, but the record does not explain the reason for termination or state how enrollment compared with any planned target. The reason for termination is not reported in the registry record. The record also does not provide numerical results for the listed secondary outcomes, change in PaO2/FiO2 ratio and ventilator-free days.
Safety information is limited to event counts and a list of serious-event terms with percentages. The registry does not report a comparative statistical analysis, confidence intervals, or the denominator rules for the listed percentages. These limitations constrain interpretation of both efficacy and safety; they do not demonstrate that an unreported outcome was absent or that no analysis was performed outside the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Comparative Evaluation of Albumin and Starch Effects in Acute Lung Injury (ALI) — NCT00796419.
- Registry record last updated 2017-04-28; status last verified 2017-03.
- Results first posted 2017-04-28.
- 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
The registry record describes a randomized, quadruple-masked, parallel-group Phase III trial sponsored by Emory University. It compared intravenous 5% human albumin with intravenous 6% hetastarch in patients with acute lung injury or acute respiratory distress syndrome and low blood protein levels. Enrollment was 31; the study is listed as terminated.
The primary endpoint was change in extravascular lung water from baseline to Day 5 (120 hours), measured in mL/kg by transpulmonary thermodilution. Secondary outcomes included change in the PaO2/FiO2 ratio and ventilator-free days. Numerical results for these outcomes are not reported in the registry record. The record lists serious and other adverse-event counts and deaths, but does not provide comparative uncertainty estimates. The reason for termination, detailed analysis plan, analysis population, and missing-data methods are not reported in the registry record.