Comparison · NCT04540094-0d33b53b
5% Human Albumin Solution vs Intravenous Balanced Crystalloid: Number of Patients Developing Pulmonary Oedema
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. 5% Human Albumin Solution vs Intravenous Balanced Crystalloid: Number of Patients Developing Pulmonary Oedema. Trial comparisons, record NCT04540094-0d33b53b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04540094-0d33b53b
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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 | 0.147 | 0.0989 | 0.212 | wilson | |
| Risk in group 2 | 0.0733 | 0.0414 | 0.127 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0733 | 0.00183 | 0.146 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 1.01 | 3.98 | log | |
| Odds ratio, group 1 over group 2 | 2.17 | 1.01 | 4.66 | log | |
| Number needed to treat, for one more participant with the outcome on 5% Human Albumin Solution than on Intravenous Balanced Crystalloid | 13.6 | 6.84 | 546 | from the risk difference interval |
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 | 5% Human Albumin Solution | Participants allocated to the treatment arm will receive intravenous 5% Human Albumin Solution (HAS) administered as the sole intravenous fluid during the initial 6-hour resuscitation period. The clinician can deliver up to 10ml/kg in the first 3 hours using 250ml boluses of HAS based on clinical judgement, using clinical assessment supplemented by technology if that is their usual practice. This will be followed by repeat clinical assessment after each bolus (including vital signs; lactate testing). After 3 hours further HAS boluses up to 6 hours post-randomisation will be at clinical discretion and will be documented in the CRF. Patients in the albumin arm should not receive balanced crystalloid as a resuscitation fluid in the first 6 hours.~Human albumin: Any preparation of 5% Human Albumin Solution which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study | 22 | 150 | OG000 |
| Group 2 | Intravenous Balanced Crystalloid | Participant allocated to the usual care arm will receive intravenous balanced crystalloid administered as the sole intravenous fluid during the initial 6 hour resuscitation period. The clinician can deliver up to 30ml/kg in the first 3 hours using 250ml boluses of balanced crystalloid based on clinical judgement, using clinical assessment supplemented by technology if that is their usual practice. This will be followed by repeat clinical assessment after each bolus (including vital signs; lactate testing). Thereafter, further crystalloid boluses up to 6 hours will be at the discretion of the clinical team and will be documented in the CRF. Patients in the balanced crystalloid arm should not receive albumin as a resuscitation fluid in the first 6 hours.~Balanced crystalloid solution: Any preparation of intravenous balanced crystalloid which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study. | 11 | 150 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients Developing Pulmonary Oedema
- Description
- Safety Radiology diagnosis or requirement for rescue management (new diuretic use)
- Time frame
- 7 days
- Population
Source ClinicalTrials.gov
Trial
- Title
- Feasibility of 5% Albumin Compared With Balanced Crystalloid, as Intravenous Fluid Resuscitation in Adult Patients With Sepsis, Presenting as an Emergency to Hospital
- NCT number
- NCT04540094
- Phases
- PHASE3
- Conditions
- Sepsis
- Interventions
- Human albumin, Balanced crystalloid solution
- Lead sponsor
- University of Edinburgh
- Results first posted
- 2024-10-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04540094?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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