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Rapid Reversal of CNS-Depressant Drug Effect Prior to Brain Death Determination

NCT03743805 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2024-10-31

No results posted yet for this study

Summary

Current standard of care prior to determination of brain death in subjects with suspected anoxic brain injury is to exclude complicating medical conditions that may confound clinical assessment (such as severe electrolyte, acid base, endocrine or circulatory disturbance), achieve normothermia and normal systolic blood pressure over 100 mmHg (with or without vasopressor use), exclude the presence of neuromuscular blocking agents (with the presence of a train of 4 twitches with maximal ulnar nerve stimulation) as well as to exclude the presence of CNS depressant drug effects. At the present time the latter is done by history, drug screen and allowing enough time for paralytic and sedative drugs to be metabolized and cleared from the body. Clearance is calculated by using 5 times the drug's half-life assuming normal hepatic and renal functions. Half-life can also be prolonged in subjects who have been treated with induced hypothermia. Literature search revealed articles with general guidelines and approaches to brain death, but none addressed pharmacological reversal of sedative drugs

Conditions

  • Brain Death
  • Anoxic Brain Injury
  • Cardiac Arrest
  • Sedative Intoxication
  • Narcotic Intoxication

Interventions

DRUG

Flumazenil

0.2 mg IV push, which may be repeated every 20 minutes for up to a total of 1 mg

DRUG

Naloxone

0.4 mg IV push, which may be repeated every 2 minutes for up to a total of 2 mg

Sponsors & Collaborators

  • Prisma Health-Midlands

    lead OTHER

Principal Investigators

  • Sameh R Hanna, MD · Palmetto Health-University of South Carolina Medical Group

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-07-20
Completion
2021-07-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03743805 on ClinicalTrials.gov