Comparison · NCT03668236-b2576284
Fluid Restriction Group vs Standard-care: Number of Participants With One or More Serious Adverse Reactions (SARs) to IV Crystalloids 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 Reactions (SARs) to IV Crystalloids in the ICU. Trial comparisons, record NCT03668236-b2576284. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03668236-b2576284
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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 | 0.0411 | 0.0291 | 0.0577 | wilson | |
| Risk in group 2 | 0.0412 | 0.0294 | 0.0576 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000178 | -0.0205 | 0.0203 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.996 | 0.614 | 1.62 | log | |
| Odds ratio, group 1 over group 2 | 0.996 | 0.601 | 1.65 | log | |
| Number needed to treat, for one fewer participant with the outcome on Fluid Restriction Group than on Standard-care | 5,630 | 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) | 31 | 755 | OG000 |
| Group 2 | Standard-care | No upper limit for IV fluids (additional details in protocol section). | 32 | 776 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With One or More Serious Adverse Reactions (SARs) to IV Crystalloids in the ICU.
- Description
The pre-specified SARs to IV crystalloids were: Generalized tonic-clonic seizures, anaphylactic reactions, central pontine myelinolysis, severe hypernatremia, severe hyperchloremic acidosis, and severe metabolic alkalosis. Data on the outcome measures, including SARs, were obtained from patient medical records by the trial investigators or their delegates.
- 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).
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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