Comparison · NCT03668236-sae
Fluid Restriction Group vs Standard-care: 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. Fluid Restriction Group vs Standard-care: serious adverse events. Trial comparisons, record NCT03668236-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03668236-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 | 0.293 | 0.261 | 0.326 | wilson | |
| Risk in group 2 | 0.307 | 0.275 | 0.34 | wilson | |
| Risk difference, group 1 minus group 2 | -0.014 | -0.0597 | 0.0319 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.954 | 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 a serious adverse event on Fluid Restriction Group than on Standard-care | 71.5 | 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 | 755 | EG000 |
| Group 2 | Standard-care | No upper limit for IV fluids (additional details in protocol section). | 238 | 776 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events were assessed until ICU discharge, maximum 90 days. All-cause mortality was assessed during ICU stay and continued following discharge from the ICU to 90 days and 1-year from randomization, respectively. At risk population for mortality at 90 days was 764 in the restrictive group and 781 in the standard group. At 1-year, the at risk population for mortality was 750 patients in the fluid restriction group, and 767 in the standard group, due to withdrawn consent.
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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