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Comparison · NCT03869385-deaths

Albumin Group vs Control Group Without Albumin:: deaths from any cause

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Albumin Group vs Control Group Without Albumin:: deaths from any cause. Trial comparisons, record NCT03869385-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03869385-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.410.3470.476wilson
Risk in group 20.440.3760.507wilson
Risk difference, group 1 minus group 2-0.0305-0.1220.0615newcombe hybrid score
Risk ratio, group 1 over group 20.9310.7491.16log
Odds ratio, group 1 over group 20.8830.6051.29log
Number needed to treat, for one fewer death from any cause on Albumin Group than on Control Group Without Albumin:32.8from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Albumin 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.
91222EG000
Group 2Control 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.96218EG001

Harm

What it counts
Total, all-cause mortality
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

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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