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

Completed · Phase 2 · Has a placebo group

Conditions studied: Critically Ill, Respiratory Failure

In brief

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.

Key facts

Study ID

NCT01985685

Run by

Beth Israel Deaconess Medical Center

People needed

66

Starts

2013-10-01

Expected to finish

2016-12-01

Last updated by the study team

2017-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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