Comparison · NCT03668236-bd3355ce
Fluid Restriction Group vs Standard-care: Number of Participants With One or More Serious Adverse Events (SAEs) in the ICU
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. Fluid Restriction Group vs Standard-care: Number of Participants With One or More Serious Adverse Events (SAEs) in the ICU. Trial comparisons, record NCT03668236-bd3355ce. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03668236-bd3355ce
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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 | 0.294 | 0.263 | 0.328 | wilson | |
| Risk in group 2 | 0.308 | 0.277 | 0.342 | wilson | |
| Risk difference, group 1 minus group 2 | -0.014 | -0.06 | 0.0321 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.955 | 0.819 | 1.11 | log | |
| Odds ratio, group 1 over group 2 | 0.936 | 0.752 | 1.16 | log | |
| Number needed to treat, for one fewer participant with the outcome on Fluid Restriction Group than on Standard-care | 71.3 | 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 | Fluid Restriction Group | No IV fluids unless one of the extenuating circumstances occurred (additional details in protocol section) | 221 | 751 | OG000 |
| Group 2 | Standard-care | No upper limit for IV fluids (additional details in protocol section). | 238 | 772 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With One or More Serious Adverse Events (SAEs) in the ICU
- Description
- SAEs were defined as ischaemic events (cerebral, cardiac, intestinal or limb ischaemia) or as a new episode of severe acute kidney injury (modified KDIGO-3)
- Time frame
- Until ICU discharge, maximum 90 days
- Population
All secondary outcome data were missing for 23 patients (15 patients in the restrictive-fluid group and 8 in the standard-fluid group). In the analysis of SAEs in the ICU, additional 9 patients (5 in the restrictive-fluid group and 4 in the standard-fluid group) had missing data for severe acute kidney injury. One of the 5 patients in the restrictive-fluid group had another SAE; thus only 8 patients had missing data in the composite outcome.
Source ClinicalTrials.gov
Trial
- Title
- The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial
- NCT number
- NCT03668236
- Phases
- PHASE4
- Conditions
- Septic Shock
- Interventions
- Isotonic crystalloids
- Lead sponsor
- Anders Perner, MD, PhD
- Results first posted
- 2025-02-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03668236?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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