Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

Randomized, Double-blind, Placebo-controlled Trial of the Effect of Thiamine on Oxygen Consumption After In-hospital Cardiac Arrest.

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.

Study Overview

• Status: Terminated
• Conditions: Shock; Cardiac Arrest; Lactic Acidosis; Thiamin Deficiency
• Intervention / Treatment: Drug: Thiamine; Other: placebo

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lactate	The investigators will evaluate the median lactate level over two days, compared between groups	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Consumption	The investigators will evaluate the mean oxygen consumption over two days, compared between groups	2 days
Pyruvate Dehydrogenase	The investigators will evaluate the median pyruvate dehydrogenase levels over two days, compared between groups	2 days

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Katherine M Berg, MD, Beth

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): February 7, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (Estimated): November 28, 2016

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: shock; cardiac arrest; lactate; thiamine; oxygen consumption
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Nutrition Disorders; Heart Diseases; Metabolic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Acid-Base Imbalance; Vitamin B Deficiency; Heart Arrest; Acidosis; Acidosis, Lactic; Thiamine Deficiency; Beriberi; Physiological Effects of Drugs; Micronutrients; Vitamin B Complex; Vitamins; Thiamine
• Other Study ID Numbers: 2016P000347; 1K23HL128814-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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