Thiamine vs. Placebo to Increase Oxygen Consumption After Cardiac Arrest

Description

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 Start Date

May, 01 2017

Estimated Completion Date

August 2021

Interventions

  • Drug: Thiamine
  • Other: placebo

Study ID

Beth Israel Deaconess Medical Center -- 2016P000347

Status

Recruiting

Trial ID

NCT02974257

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

100

Sponsor

Beth Israel Deaconess Medical Center

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
  • Ventilator settings in excess of fraction of inspired oxygen (FiO2) of 0.6 or positive end expiratory pressure (PEEP) of 15cm of water
  • Severe agitation
  • Protected populations (pregnant women, prisoners)

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Katherine M Berg MD 617-667-5864 kberg@bidmc.harvard.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Katherine M Berg MD 617-667-5864 kberg@bidmc.harvard.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Katherine M Berg MD 617-667-5864 kberg@bidmc.harvard.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Katherine M Berg MD 617-667-5864 kberg@bidmc.harvard.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Katherine M Berg MD 617-667-5864 kberg@bidmc.harvard.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.