Comparison · NCT03869385-sae
Albumin Group vs Control Group Without Albumin:: serious adverse events
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:: serious adverse events. Trial comparisons, record NCT03869385-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03869385-sae
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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 | 0.0135 | 0.00461 | 0.039 | wilson | |
| Risk in group 2 | 0.00917 | 0.00252 | 0.0328 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00434 | -0.0209 | 0.0307 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.47 | 0.249 | 8.73 | log | |
| Odds ratio, group 1 over group 2 | 1.48 | 0.245 | 8.94 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Albumin Group than on Control Group Without Albumin: | 230 | 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. | 3 | 222 | EG000 |
| 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. | 2 | 218 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
In the albumin group until 24 h after the last dose of the trial drug Iin the control group without albumin until day 28 after randomisation or until discharge from the ICU, if it occurs before day 28 after randomisation. In the event that adverse events are still ongoing after the above dates, they were tracked until maximum the end of data collection (Day 90). If they are ongoing on day 90, they were documented as not recovered, recovered with sequelae, or unknown.
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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