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Trial record 19 of 39 for:    FLUMAZENIL

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

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ClinicalTrials.gov Identifier: NCT03743805
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sameh Hanna, MD, Prisma Health-Midlands

Brief 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

Condition or disease Intervention/treatment Phase
Brain Death Anoxic Brain Injury Cardiac Arrest Sedative Intoxication Narcotic Intoxication Drug: Flumazenil Drug: Naloxone Early Phase 1

Detailed Description:

Question of proposed study is whether a subject's comatose state is secondary to delayed clearance of a previously administered CNS depressant. By using pharmacologic reversal agents of commonly used benzodiazepines and opioids, the investigators aim to identify participants that may likely improve after complete clearance of the drugs from their system.

Prospective trial with enrollment of 30 subjects in 2 intensive care units at Palmetto Health Richland from January 1st 2019 to June 30th 2020. Research procedures will be performed in the intensive care setting. If participants had undergone targeted temperature management (33-36 degrees Celsius for 24 hours via intravascular or surface control methods, with or without sedation or neuromuscular blockade, followed by rewarming actively or passively at 0.25-0.5 degrees per hour over 8-12 hours to 37 degrees) investigators will wait 24 hours after rewarming prior to testing. End point is to evaluate if pharmacological reversal agents would result in improved GCS scores or return of cerebral or brainstem functions in some comatose subjects, which will be considered a positive test result.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Rapid Reversal of CNS-Depressant Drug Effect Prior to Brain Death Determination
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Reversal drugs
Flumazenil and naloxone
Drug: Flumazenil
0.2 mg IV push, which may be repeated every 20 minutes for up to a total of 1 mg
Other Name: Romazicon

Drug: Naloxone
0.4 mg IV push, which may be repeated every 2 minutes for up to a total of 2 mg
Other Names:
  • Narcan
  • Evzio




Primary Outcome Measures :
  1. Improved GCS scores or return of cerebral or brainstem functions in comatosed subjects [ Time Frame: Within 30 minutes post treatment ]
    Subjects will be observed closely and tested before and after intervention for any signs of cerebral or brainstem function (1-Response to pain stimulus with earlobe pinching, trapezius squeezing and sternal rub or other brain-originating movements, e.g. seizures, decerebrate or decorticate posturing. 2-Pupillary light reflex with bright light. 3-Corneal reflexes with the use of cotton swab or tissue paper. 4-Gag reflex with a tongue depressor looking for bilateral palatal elevation. 5-Cough with tracheal suctioning at the carinal level) and GCS re-evaluated



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults with cardiac arrest who may have completed targeted temperature management (hypothermia protocol) and have had no neurological recovery after 24 hours of rewarming will be enrolled. Subjects will have a suspected diagnosis of anoxic brain injury secondary to cardiac arrest, and seizures ruled out with an EEG. All subjects are expected to be unable to consent and consent will be obtained from their legal authorized representative.

Exclusion Criteria:

  • Spontaneous recovery of neurological functions, presence of seizures on EEG, individuals who are not yet adults, pregnant women and prisoners.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743805


Contacts
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Contact: Sameh R Hanna, MD 8643443439 samehmakar@hotmail.com
Contact: Justin H Atwood, MD 8646084557 justin.h.atwood@gmail.com

Locations
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United States, South Carolina
PRISMA Health Midlands Recruiting
Columbia, South Carolina, United States, 29203
Principal Investigator: Sameh R Hanna, MD         
Principal Investigator: Justin H Atwood, MD         
Sponsors and Collaborators
Sameh Hanna, MD
Investigators
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Principal Investigator: Sameh R Hanna, MD Palmetto Health-University of South Carolina Medical Group

Publications:

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Responsible Party: Sameh Hanna, MD, Pulmonary and Critical Care Fellow, Prisma Health-Midlands
ClinicalTrials.gov Identifier: NCT03743805     History of Changes
Other Study ID Numbers: Pro00077995
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Sameh Hanna, MD, Prisma Health-Midlands:
brain
death
sedative
narcotic
Additional relevant MeSH terms:
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Flumazenil
Brain Injuries
Brain Death
Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Naloxone
Central Nervous System Depressants
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidotes
Protective Agents
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action