Thiamine as a Metabolic Resuscitator After Cardiac Arrest

Thiamine as a Metabolic Resuscitator After Cardiac Arrest

Sponsors

Lead Sponsor: Michael Donnino

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Source Beth Israel Deaconess Medical Center
Brief 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.

Overall Status Recruiting
Start Date 2018-05-06
Completion Date 2023-02-01
Primary Completion Date 2023-02-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
lactate 24 hours
Secondary Outcome
Measure Time Frame
Pyruvate dehydrogenase various time points over 72 hours
global oxygen consumption 48 hours
biomarkers of neurologic injury various time points over 7 days
cellular oxygen consumption various time points over 72 hours
Cerebral Performance Category-Extended (score) will be assessed up to 30 and 90 days
Renal failure up to 90 days
Sequential Organ Failure Assessment (SOFA) score compared at various time points over 7 days
Mortality will be assessed up to 30 and 90 days.
Enrollment 92
Condition
Intervention

Intervention Type: Drug

Intervention Name: Thiamine 500 mg IV

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

Arm Group Label: Thiamine

Other Name: vitamin B1

Intervention Type: Other

Intervention Name: Placebo

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

Arm Group Label: Placebo

Other Name: Normal saline

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Michael W Donnino, MD Principal Investigator Beth Israel Deaconess Medical Center
Overall Contact

Last Name: Michael W Donnino, MD

Phone: 617-754-2341

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Beth Israel Deaconess Medical Center Katherine M Berg, MD 617-667-5864 [email protected] Katherine M Berg, MD Principal Investigator
Location Countries

United States

Verification Date

2020-07-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Beth Israel Deaconess Medical Center

Investigator Full Name: Michael Donnino

Investigator Title: Associate Professor of Medicine and Emergency Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Thiamine

Type: Experimental

Description: Patients randomized to the thiamine arm will receive thiamine 500mg in 100mL of normal saline intravenously every 12 hours for 5 doses. Patients will be connected to a noninvasive monitor for measurement of global oxygen consumption (VO2) for at least 48 hours or until extubated, whichever comes first. Blood will be drawn at 0,6,12,24,72 and 168 hours for measurement of lactate, thiamine level, pyruvate dehydrogenase, NSE, S100 and other markers of organ injury. CPC-E score will be assessed prior to hospital discharge and at 30 and 90 days to evaluate differences in neurologic and functional impairment.

Label: Placebo

Type: Placebo Comparator

Description: Patients randomized to placebo will receive 100mL normal saline intravenously every 12 hours for 5 doses. All other aspects of the protocol will be the same as in the experimental arm. Patients will be connected to a noninvasive monitor for measurement of global oxygen consumption (VO2) for at least 48 hours or until extubated, whichever comes first. Blood will be drawn at 0,6,12,24,72 and 168 hours for measurement of lactate, thiamine level, pyruvate dehydrogenase, NSE, S100 and other markers of organ injury. CPC-E score will be assessed prior to hospital discharge and at 30 and 90 days to evaluate differences in neurologic and functional impairment.

Acronym THACA
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: A randomization list was prepared by an independent statistician using 1:1 randomization in blocks of four. This list will be provided to the research pharmacy, and the research pharmacy will be the only unblinded people involved with the study, and will have no patient contact or role in the analysis or other aspects of the study. Thiamine is colorless and odorless, and the 500mg dose is mixed in 100mL of normal saline. Placebo will be 100mL of normal saline and is indistinguishable in appearance from thiamine. Study team, clinical team and patient and family will all be blind to the allocation.

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