Comparison · NCT03869385-4aeff39a
Albumin Group vs Control Group Without Albumin:: 60-day Mortality
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Albumin Group vs Control Group Without Albumin:: 60-day Mortality. Trial comparisons, record NCT03869385-4aeff39a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03869385-4aeff39a
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.389 | 0.325 | 0.456 | wilson | |
| Risk in group 2 | 0.452 | 0.387 | 0.52 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0638 | -0.156 | 0.0303 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.859 | 0.686 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 0.769 | 0.522 | 1.13 | log | |
| Number needed to treat, for one fewer participant with the outcome on Albumin Group than on Control Group Without Albumin: | 15.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Albumin Group | Patients assigned to the Albumin group received a 60 g loading dose of human albumin 20% over 2-3 hours. Serum albumin levels were maintained at least at 30 g/l in the ICU for a maximum of 28 days following randomization using 40-80 g human albumin 20% infusion. | 82 | 211 | OG000 |
| Group 2 | Control Group Without Albumin: | The control group was treated according to the usual practice with crystalloids as the first choice for the resuscitation and maintenance phase of septic shock. | 95 | 210 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- 60-day Mortality
- Description
- Mortality within 60 days after randomisation
- Time frame
- 60 days
- Population
At 60 days after randomization, informed consent was not possible to be obtained within 72 hours of randomization in 14 patients, 2 patients withdrew consent, 2 patients were lost to follow-up, and the study was terminated in one patient due to investigator decision. Therefore, 60-days mortality were available in 211 vs. 210 patients in the albumin vs. control group, respectively
Source ClinicalTrials.gov
Trial
- Title
- Albumin Replacement Therapy in Septic Shock
- NCT number
- NCT03869385
- Phases
- PHASE3
- Conditions
- Septic Shock
- Interventions
- Albutein® 200 g/L or Plasbumin® 20
- Lead sponsor
- Jena University Hospital
- Results first posted
- 2024-10-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03869385?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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