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Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

Primary Purpose

Cardiac Arrest, Shock, Lactic Acidosis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thiamine
placebo
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiac arrest, thiamine, oxygen consumption, lactate, shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patient (age > 18 years)
  • Cardiac arrest occurring while admitted to the hospital, with sustained (>20 minutes) return of spontaneous circulation (ROSC)
  • Mechanically ventilated at the time of enrollment
  • Within 12 hours of cardiac arrest event

Exclusion Criteria:

  • Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
  • Comfort measures only or anticipated withdrawal of support within 24 hours
  • Severe agitation
  • Protected populations (pregnant women, prisoners)

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Thiamine

Placebo

Arm Description

Intervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.

Intervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.

Outcomes

Primary Outcome Measures

lactate
The investigators will evaluate the absolute level and the change in lactate over two days, compared between groups

Secondary Outcome Measures

oxygen consumption
The investigators will evaluate the absolute level and the change in oxygen consumption over two days, compared between groups
Pyruvate dehydrogenase
The investigators will evaluate the absolute level and the change in pyruvate dehydrogenase levels over two days, compared between groups

Full Information

First Posted
November 23, 2016
Last Updated
August 5, 2022
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02974257
Brief Title
Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest
Official Title
Randomized, Double-blind, Placebo-controlled Trial of the Effect of Thiamine on Oxygen Consumption After In-hospital Cardiac Arrest.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Study stopped early after consultation with DSMB
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
February 7, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to evaluate whether thiamine can increase oxygen consumption and lower lactate in patients who initially survive an in-hospital cardiac arrest. Patients who are successfully resuscitated after an in-hospital cardiac arrest and who are on mechanical ventilation in the intensive care unit will be enrolled, and will get either thiamine or placebo. Their oxygen consumption and lactate will be measured at serial time points and compared between groups. The investigators' hypothesis is that thiamine will help restore the body's ability to metabolize oxygen normally (aerobic metabolism), leading to an increase in oxygen consumption and a decrease in lactate.
Detailed Description
In-hospital cardiac arrest often leads to shock and organ failure, and low oxygen consumption and high lactate are associated with worse outcome. Thiamine is a B vitamin necessary to maintain the body's ability to use oxygen effectively, and the investigators have found that many patients are thiamine deficient after cardiac arrest. The investigators have also found that thiamine can decrease lactate in thiamine-deficient patients who are critically ill. Patients in this study will be randomized to receive either thiamine or placebo every 12 hours for 2 days after surviving an in-hospital cardiac arrest. The investigators will measure oxygen consumption continuously during that time with a monitor attached to the ventilator tubing, and will also measure lactate and other lab values at several time points.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Shock, Lactic Acidosis, Thiamin Deficiency
Keywords
cardiac arrest, thiamine, oxygen consumption, lactate, shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thiamine
Arm Type
Experimental
Arm Description
Intervention: Thiamine 500mg IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intervention: Placebo (100mL normal saline) IV every 12 hours for 2 days. Oxygen consumption will be monitored with a non-invasive monitor continuously for 2 days and lactate, pyruvate dehydrogenase and other routine lab values will be checked at serial time points.
Intervention Type
Drug
Intervention Name(s)
Thiamine
Other Intervention Name(s)
vitamin B1
Intervention Description
Thiamine 500mg IV twice daily for 2 days
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
normal saline
Intervention Description
100mL normal saline IV every 12 hours for 2 days
Primary Outcome Measure Information:
Title
lactate
Description
The investigators will evaluate the absolute level and the change in lactate over two days, compared between groups
Time Frame
2 days
Secondary Outcome Measure Information:
Title
oxygen consumption
Description
The investigators will evaluate the absolute level and the change in oxygen consumption over two days, compared between groups
Time Frame
2 days
Title
Pyruvate dehydrogenase
Description
The investigators will evaluate the absolute level and the change in pyruvate dehydrogenase levels over two days, compared between groups
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patient (age > 18 years) Cardiac arrest occurring while admitted to the hospital, with sustained (>20 minutes) return of spontaneous circulation (ROSC) Mechanically ventilated at the time of enrollment Within 12 hours of cardiac arrest event Exclusion Criteria: Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days Comfort measures only or anticipated withdrawal of support within 24 hours Severe agitation Protected populations (pregnant women, prisoners)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine M Berg, MD
Organizational Affiliation
Beth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

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