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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Thiamine

Criteria

Inclusion Criteria:

1. Adult patients (age > 18 yrs) admitted to an ICU

2. Mechanically ventilated for an acute illness, with stable respiratory status (no changes in ventilator settings in the 3 hours prior to enrollment)

3. 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.

4. Upper central venous line in place

Exclusion Criteria:

1. Unstable ventilator settings during measurement of VO2

2. Temperature >100.5

3. FIO2>60%

4. Endotracheal cuff leak, chest tube, or other evident source of air leak

5. Positive end expiratory pressure > 12cmH2O

6. Intravenous thiamine supplementation within 2 weeks of enrollment, or oral supplementation more than that found in a multivitamin.

7. Protected populations (pregnant woman, prisoners, cognitively impaired)