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Comparison · NCT01424150-48cac7cd

Liberal vs Restrictive: Pneumonia

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. Liberal vs Restrictive: Pneumonia. Trial comparisons, record NCT01424150-48cac7cd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01424150-48cac7cd

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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 10.03650.02810.0473wilson
Risk in group 20.03830.02970.0493wilson
Risk difference, group 1 minus group 2-0.00187-0.01570.012newcombe hybrid score
Risk ratio, group 1 over group 20.9510.661.37log
Odds ratio, group 1 over group 20.9490.651.39log
Number needed to treat, for one fewer participant with the outcome on Liberal than on Restrictive535from 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 1Liberal
At the commencement of surgery a bolus of Hartmann's balanced salt crystalloid 10 ml/kg followed by 8 ml/kg/h will be administered until the end of surgery. A maintenance infusion will then continue at 1.5 ml/kg/h, for at least 24 hours, but this can be reduced postoperatively if there is evidence of fluid overload and no hypotension, and increased if there is evidence of hypovolaemia or hypotension. Alternative fluid types (crystalloid, dextrose, colloid) and electrolyte supplements will be allowed postoperatively in order to account for local preferences and patient biochemistry, for which we will collect data.~Liberal fluid therapy: Liberal protocol group is designed to provide approximately 6.0L per day.
541,481OG000
Group 2Restrictive
Will provide less than 2.0 L water and 120 mmol sodium per day. Induction of anaesthesia will limit IV bolus fluid to ≤5 ml/kg; no other IV fluids will be used at the commencement of surgery (unless indicated by goal-directed device \[see below\]). Hartmann's balanced salt crystalloid 5 ml/kg/h will be administered until the end of surgery, and bolus colloid/blood used intraoperatively to replace blood loss (ml for ml); then an infusion at 1 ml/kg/h until expedited cessation of IV fluid therapy within 24 hours. The rate of postoperative fluid replacement can be reduced if there is evidence of fluid overload and no hypotension, and can be increased if there is hypotension AND evidence of hypovolaemia.~Restrictive fluid therapy: Restrictive protocol group is designed to provide less than 2.0 L water and 120 mmol sodium per day.
571,487OG001

Outcome

Type
SECONDARY
Title
Pneumonia
Description
The presence of new and/or progressive pulmonary infiltrates on chest radiograph plus two or more of the following:~1. Fever ≥ 38.5°C or postoperative hypothermia \<36°C~2. Leukocytosis ≥ 12,000 WBC/mm3 or leukopenia \< 4,000 WBC/mm3~3. Purulent sputum and/or~4. New onset or worsening cough or dyspnoea.
Time frame
30 Days postoperative
Population

Source ClinicalTrials.gov

Trial

Title
REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery: RELIEF Study
NCT number
NCT01424150
Phases
NA
Conditions
Abdominal Surgery
Interventions
Liberal fluid therapy, Restrictive fluid therapy
Lead sponsor
Bayside Health
Results first posted
2025-01-24

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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