Phase 2 N=56 Randomized Quadruple-blind Treatment

The Effect of Thiamine vs. Placebo on VO2 in Critical Illness

Critically Ill · Respiratory Failure

Bottom Line

View on ClinicalTrials.gov: NCT01985685 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcome: Primary: Change in VO2 Over Time — 4.2; 4.3 ml/kg/min

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Thiamine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: May 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in VO2 Over Time	4.2; 4.3	—
SECONDARY Percentage Change in Serum Lactate	-9; -8	—
SECONDARY Change in Central Venous Oxygen Saturation	0; 3	—

Summary

The objective of this study is to determine the effect of thiamine therapy on oxygen consumption (VO2) in critically-ill patients. We will evaluate this by measuring VO2 before and after thiamine or placebo administration in patients admitted to the ICU and requiring mechanical ventilation. A secondary aim is to evaluate the effect of thiamine vs. placebo on the metabolic profile of the patients.

Eligibility Criteria

Inclusion Criteria

Adult patients (age > 18 yrs) admitted to an ICU
Mechanically ventilated for an acute illness, with stable respiratory status (no changes in ventilator settings in the 3 hours prior to enrollment)
Cardiac index >2.4L/min/m2 as measured by Noninvasive Cardiac Output Monitor(NICOM) by Cheetah Medical or, if being used clinically, by PA catheter or Vigileo device.
Upper central venous line in place

Exclusion Criteria

Unstable ventilator settings during measurement of VO2
Temperature >100.5
FIO2>60%
Endotracheal cuff leak, chest tube, or other evident source of air leak
Positive end expiratory pressure > 12cmH2O
Intravenous thiamine supplementation within 2 weeks of enrollment, or oral supplementation more than that found in a multivitamin.
Protected populations (pregnant woman, prisoners, cognitively impaired)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01985685). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.