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Comparison · NCT03434028-768d1c5f

Restrictive Fluids vs Liberal Fluids: New Onset Atrial or Ventricular Arrhythmia

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. Restrictive Fluids vs Liberal Fluids: New Onset Atrial or Ventricular Arrhythmia. Trial comparisons, record NCT03434028-768d1c5f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03434028-768d1c5f

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.07570.05920.0965wilson
Risk in group 20.08610.06840.108wilson
Risk difference, group 1 minus group 2-0.0104-0.03780.0169newcombe hybrid score
Risk ratio, group 1 over group 20.8790.6291.23log
Odds ratio, group 1 over group 20.870.6041.25log
Number needed to treat, for one fewer participant with the outcome on Restrictive Fluids than on Liberal Fluids96.3from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Restrictive 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.
59779OG000
Group 2Liberal 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.
67778OG001

Outcome

Type
SECONDARY
Title
New Onset Atrial or Ventricular Arrhythmia
Description
The occurrence of one or more episodes (sustained for more than 1 minute for SVT and AF, \> 15 seconds for VT) during through day 28 will be recorded.
Time frame
28 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

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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