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Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT02974257
Recruitment Status : Terminated (Study stopped early after consultation with DSMB)
First Posted : November 28, 2016
Last Update Posted : August 9, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Katherine Berg, Beth Israel Deaconess Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Shock Lactic Acidosis Thiamin Deficiency Drug: Thiamine Other: placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled Trial of the Effect of Thiamine on Oxygen Consumption After In-hospital Cardiac Arrest.
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : February 7, 2022
Actual Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Thiamine
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.
 Drug: Thiamine
Thiamine 500mg IV twice daily for 2 days
Other Name: vitamin B1
Placebo Comparator: Placebo
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.
 Other: placebo
100mL normal saline IV every 12 hours for 2 days
Other Name: normal saline


Outcome Measures
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Primary Outcome Measures :
  1. lactate [ Time Frame: 2 days ]
    The investigators will evaluate the absolute level and the change in lactate over two days, compared between groups


Secondary Outcome Measures :
  1. oxygen consumption [ Time Frame: 2 days ]
    The investigators will evaluate the absolute level and the change in oxygen consumption over two days, compared between groups

  2. Pyruvate dehydrogenase [ Time Frame: 2 days ]
    The investigators will evaluate the absolute level and the change in pyruvate dehydrogenase levels over two days, compared between groups


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974257


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Katherine M Berg, MD Beth
  Study Documents (Full-Text)

Documents provided by Katherine Berg, Beth Israel Deaconess Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] August 4, 2022

More Information
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Responsible Party: Katherine Berg, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02974257    
Other Study ID Numbers: 2016P000347
1K23HL128814-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Katherine Berg, Beth Israel Deaconess Medical Center:
cardiac arrest
thiamine
oxygen consumption
lactate
shock
Additional relevant MeSH terms:
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Heart Arrest
Acidosis
Acidosis, Lactic
Thiamine Deficiency
Beriberi
Heart Diseases
Cardiovascular Diseases
Acid-Base Imbalance
Metabolic Diseases
Vitamin B Deficiency
 Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Thiamine
Vitamins
Micronutrients
Physiological Effects of Drugs
Vitamin B Complex