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Comparison · NCT03550794-4e5b30cd

Thiamine vs Placebo: Number of Participants Experiences Acute Renal Failure

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. Thiamine vs Placebo: Number of Participants Experiences Acute Renal Failure. Trial comparisons, record NCT03550794-4e5b30cd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03550794-4e5b30cd

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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 10.5480.3990.688wilson
Risk in group 20.7390.5970.844wilson
Risk difference, group 1 minus group 2-0.192-0.3730.0078newcombe hybrid score
Risk ratio, group 1 over group 20.7410.5361.02log
Odds ratio, group 1 over group 20.4270.1741.05log
Number needed to treat, for one fewer participant with the outcome on Thiamine than on Placebo5.22from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Thiamine
200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)~Thiamine Hydrochloride: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.
2342OG000
Group 2PlaceboMatching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)~Placebo: 50ml of 0.9% NACL will serve as the placebo3446OG001

Outcome

Type
SECONDARY
Title
Number of Participants Experiences Acute Renal Failure
Description
Acute renal failure as defined by the KDIGO (Kidney Disease Improving Global Outcomes) AKI (Acute Kidney Injury) criteria. In brief, a patient can meet these criteria if their serum creatinine increases (for example, serum creatinine increases to 1.5x or higher of baseline serum creatinine, or if it crosses 4mg/dL), or if renal replacement therapy is initiated, or if urine output decreases (for example, \<0.5ml/kg/hour for 6-12 hours) or if patient becomes anuric (no urine production).
Time frame
From date of enrollment until day of discharge from the index ICU admission or date of death, whichever comes first up until 60 days post-enrollment
Population

Source ClinicalTrials.gov

Trial

Title
Thiamine as a Renal Protective Agent in Septic Shock
NCT number
NCT03550794
Phases
PHASE2
Conditions
Sepsis, Kidney Injury, Thiamine Deficiency
Interventions
Thiamine Hydrochloride, Placebo
Lead sponsor
Beth Israel Deaconess Medical Center
Results first posted
2023-06-27

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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