NCT03450707

Thiamine as a Metabolic Resuscitator After Cardiac Arrest

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Michael Donnino · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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). .

Detailed description

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.

Conditions

• Cardiac Arrest

Interventions

Type	Name	Description
DRUG	Thiamine 500 mg IV	Thiamine hydrochloride (vitamin B1) 500mg IV will be given every 12 hours for 5 doses in the experimental arm.
OTHER	Placebo	100mL of intravenous normal saline will be given every 12hours for 5 doses in the placebo arm

Timeline

• Start date: 2018-05-06
• Primary completion: 2022-02-19
• Completion: 2022-02-19
• First posted: 2018-03-01
• Last updated: 2023-08-24
• Results posted: 2023-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study