Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02974257
• Other study ID #: 2016P000347
• Secondary ID: 1K23HL128814-01A
• Status: Terminated
• Phase: Phase 2
• Start date: May 1, 2017
• Est. completion date: August 1, 2022

Study information

• Verified date: August 2022
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: August 1, 2022
• Est. primary completion date: February 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acidosis
• Acidosis, Lactic
• Beriberi
• Cardiac Arrest
• Heart Arrest
• Lactic Acidosis
• Shock
• Thiamin Deficiency
• Thiamine Deficiency

Intervention

Drug:
• Thiamine
Thiamine 500mg IV twice daily for 2 days

Other:
• placebo
100mL normal saline IV every 12 hours for 2 days

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lactate	The investigators will evaluate the absolute level and the change in lactate over two days, compared between groups	2 days
Secondary	oxygen consumption	The investigators will evaluate the absolute level and the change in oxygen consumption over two days, compared between groups	2 days
Secondary	Pyruvate dehydrogenase	The investigators will evaluate the absolute level and the change in pyruvate dehydrogenase levels over two days, compared between groups	2 days