Effect of Thiamine on Oxygen Utilization (VO2) in Critical Illness
VO2
The Effect of Thiamine on VO2 Levels in Critically Ill Patients
1 other identifier
interventional
20
1 country
1
Brief Summary
The objective of this study is to determine the effect of thiamine therapy on oxygen consumption in critically-ill patients. The investigators will evaluate this by measuring VO2 before and after thiamine administration in patients admitted to the ICU and requiring mechanical ventilation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 25, 2011
CompletedFirst Posted
Study publicly available on registry
October 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
November 30, 2016
CompletedJanuary 16, 2018
December 1, 2017
1.1 years
October 25, 2011
October 7, 2016
December 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in VO2
VO2 measurements are taken at baseline and VO2 is continuously monitored over 9 hours. Thiamine is administered three hours after baseline measurements are taken.
Baseline to 9 Hours
Secondary Outcomes (1)
Improvement in Hemodynamics
Baseline to Nine Hours
Study Arms (1)
Thiamine
EXPERIMENTALOpen label - 200mg IV
Interventions
200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once
Eligibility Criteria
You may qualify if:
- Adult patients (age \> 18 years) admitted to an ICU
- Mechanically ventilated
You may not qualify if:
- Unstable ventilator settings during measurement of VO2
- Temp \> 100 at time of VO2 measurement
- FIO2 \> 60%
- Endotracheal cuff leak, chest tube, or other evident source of air leak
- Thiamine supplementation within 24 hours prior to study enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- American Medical Associationcollaborator
Study Sites (1)
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02115, United States
Related Publications (1)
Berg KM, Gautam S, Salciccioli JD, Giberson T, Saindon B, Donnino MW. Intravenous thiamine is associated with increased oxygen consumption in critically ill patients with preserved cardiac index. Ann Am Thorac Soc. 2014 Dec;11(10):1597-601. doi: 10.1513/AnnalsATS.201406-259BC.
PMID: 25390455DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael W. Donnino
- Organization
- Beth Israel Deaconess Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine M Berg, MD
Beth Israel Deaconess Medical Center
- PRINCIPAL INVESTIGATOR
Michael W Donnino, MD
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Emergency Medicine
Study Record Dates
First Submitted
October 25, 2011
First Posted
October 31, 2011
Study Start
September 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
January 16, 2018
Results First Posted
November 30, 2016
Record last verified: 2017-12