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

NCT01985685 | Completed Phase 2 Results DMC

• 1 other identifier: 2013P000240
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critically Ill; Respiratory Failure

Keywords

VO2, critically ill, oxygen consumption

Outcome Measures

Primary Outcomes (1)

• Change in VO2 Over Time

  The primary outcome will be the change in VO2 over the 6 hours after administration of the study medication, adjusted for baseline VO2.

  6 hrs

Secondary Outcomes (2)

• Percentage Change in Serum Lactate

  6 hrs

• Change in Central Venous Oxygen Saturation

  6 hrs

Study Arms (2)

Thiamine

EXPERIMENTAL

200mg intravenous thiamine in 50ml 5% dextrose, single dose

Drug: Thiamine

Placebo

PLACEBO COMPARATOR

50ml intravenous 5% dextrose, single dose

Drug: Thiamine

Interventions

Thiamine DRUG

200 mg IV thiamine

Placebo; Thiamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency

Interventions

Thiamine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

We found differences in variability in VO2 after study drug in the subgroup of patients (35%) who were thiamine deficient.

Results Point of Contact

• Title: Dr. Katherine Berg
• Organization: Beth Israel Deaconess Medical Center

617-667-5864

Study Officials

• Katherine Berg, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 15, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 2, 2017
• Results First Posted: October 2, 2017

Record last verified: 2017-09

Locations

US (1)