Thiamine as a Metabolic Resuscitator After Cardiac Arrest

Phase 2TerminatedNCT03450707

Michael Donnino93 enrolled

Overview

This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen consumption and biomarkers of neurologic injury after out-of-hospital cardiac arrest (OHCA). Patients who have sustained return of spontaneous circulation (ROSC) after OHCA and have a lactate of 3 or greater will be eligible for the study. Enrolled patients will be randomized to intravenous thiamine 500mg twice daily for 5 doses or matching placebo (100cc normal saline). Blood will be drawn at several time points and patients will be connected to a noninvasive monitor for continuous measurement of global oxygen consumption. The primary endpoint is change in lactate level. Secondary endpoints include change in pyruvate dehydrogenase activity, change in cellular and global oxygen consumption, change in NSE and S100 (biomarkers of neurologic injury) and CPC-E score (a score that assesses neurologic and functional impairment) at hospital discharge, 30 and 90 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cardiac Arrest

Interventions

Thiamine 500 mg IVDRUG

Thiamine hydrochloride (vitamin B1) 500mg IV will be given every 12 hours for 5 doses in the experimental arm.

PlaceboOTHER

100mL of intravenous normal saline will be given every 12hours for 5 doses in the placebo arm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patient (age ≥ 18 years) * Cardiac arrest occurring with sustained (\> 20 minutes) return of spontaneous circulation (ROSC) * Within 4.5 hours of cardiac arrest event * Lactate \>/=3 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 * Traumatic etiology of arrest * Comfort measures only or anticipated withdrawal of support within 24 hours * Protected populations (pregnant women, prisoners) * Known allergy to thiamine

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Lactate

Blood Lactate Over Time

Time frame: 24 hours

Secondary Outcomes

Global Oxygen Consumption

Global Oxygen Consumption over Time

Time frame: 48 hours

Lactate

Absolute Blood Level of Lactate

Time frame: 72 hours

Pyruvate Dehydrogenase (PDH) Specific Activity

Absolute PDH specific activity value

Time frame: 72 hours

Pyruvate Dehydrogenase (PDH) Activity

Absolute PDH Activity Value

Time frame: 72 hours

Pyruvate Dehydrogenase (PDH) Quantity

Absolute PDH Quantity. Please note that the measurement of Absolute PDH Quantity is done using a relative quantity assay, and that PDH is an enzyme and not a stable protein; therefore the units of measure cannot be provided in "mg" and are instead listed in "mini OD unit/min/mg protein".

Time frame: 72 hours

Mortality

Mortality in the study assessed at three timepoints.

Time frame: will be assessed at hospital discharge and up to 30 and 90 days.

Favorable Cerebral Performance Category (CPC)

Count/Proportion of Patients Scoring a Favorable CPC, defined as a score of 1 or 2. Cerebral performance category scores range from 1-5. Lower scores mean better outcomes.

Data from ClinicalTrials.gov

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