Comparison · NCT03434028-80b62b21
Restrictive Fluids vs Liberal Fluids: Development of ARDS
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. Restrictive Fluids vs Liberal Fluids: Development of ARDS. Trial comparisons, record NCT03434028-80b62b21. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03434028-80b62b21
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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 | 0.0251 | 0.0161 | 0.0389 | wilson | |
| Risk in group 2 | 0.0264 | 0.0171 | 0.0404 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00129 | -0.0179 | 0.0153 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.951 | 0.512 | 1.77 | log | |
| Odds ratio, group 1 over group 2 | 0.95 | 0.503 | 1.79 | log | |
| Number needed to treat, for one fewer participant with the outcome on Restrictive Fluids than on Liberal Fluids | 778 | 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 | Restrictive Fluids | The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.~Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. Rescue fluids may be administered as 500ml boluses if predefined rescue criteria are met. | 19 | 757 | OG000 |
| Group 2 | Liberal Fluids | The general approach is to use fluid boluses to treat hypotension.~Early Fluids: Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. Rescue vasopressors may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted. | 20 | 758 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Development of ARDS
- Description
- Presence and severity of ARDS is determined using the PaO2/FiO2 ratio or SpO2/FiO2 ratio and confirmation of ARDS through chest x-ray reviews.
- Time frame
- 7 days after randomization
- Population
Source ClinicalTrials.gov
Trial
- Title
- Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis
- NCT number
- NCT03434028
- Phases
- PHASE3
- Conditions
- Septic Shock
- Interventions
- Early Vasopressors, Early Fluids
- Lead sponsor
- Massachusetts General Hospital
- Results first posted
- 2023-07-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03434028?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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GET https://conductscience.org/api/comparisons/v1/NCT03434028-80b62b21