Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

NCT02974257 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2016P0003471K23HL128814-01A1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest; Shock; Lactic Acidosis; Thiamin Deficiency

Keywords

cardiac arrest; thiamine; oxygen consumption; lactate; shock

Outcome Measures

Primary Outcomes (1)

• Lactate

  The investigators will evaluate the median lactate level over two days, compared between groups

  2 days

Secondary Outcomes (2)

• Oxygen Consumption

  2 days

• Pyruvate Dehydrogenase

  2 days

Study Arms (2)

Thiamine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Thiamine DRUG

Thiamine 500mg IV twice daily for 2 days

Also known as: vitamin B1

Thiamine

placebo OTHER

100mL normal saline IV every 12 hours for 2 days

Also known as: normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Heart Arrest; Shock; Acidosis, Lactic; Beriberi

Interventions

Thiamine; Saline Solution

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Thiamine Deficiency; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

The trial was placed on hold after a data safety and monitoring board (DSMB) review noted possible harm from thiamine in the subgroup of patients with a lactate \>5mmol/L at the time of study inclusion, with a similar pattern seen in a companion trial in out-of-hospital cardiac arrest (NCT03450707). While the option of continuing to enroll patients with lactate ≤ 5mmol/L was provided, the trial was terminated formally in August 2022 due to lack of feasibility.

Results Point of Contact

• Title: Dr. Katherine Berg
• Organization: BIDMC

kberg@bidmc.harvard.edu

617-754-2281

Study Officials

• Katherine M Berg, MD

  Beth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 28, 2016
• Study Start: May 1, 2017
• Primary Completion: February 7, 2022
• Study Completion: August 1, 2022
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)