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Hepatic Encephalopathy | Treatment of Hepatic Encephalopathy With Flumazenil and Change in Cortical GABA Levels in MRS

Hepatic Encephalopathy research study

What is the primary objective of this study?

The purpose of this study is to test feasibility of measuring flumazenil-induced changes in cortical GABA levels observed with localized 1H-MRS in relation to changes in severity of hepatic encephalopathy (HE) in subjects with non-alcoholic liver cirrhosis. This study is a double-blind, placebo-controlled, randomized, cross-over design.

Who is eligible to participate?

Inclusion Criteria: 1. Age: 18 and older 2. ICD-9 diagnosis of hepatic encephalopathy 3. Ability to feel comfortable in confined areas (like MRI) 4. Ability to provide informed consent 5. Speaks fluent English without any communication barriers 6. Reliable family member or friend able to stay with participant during abstinence from HE medication prior to visit. Exclusion Criteria: 1. Current DSM-IV-R diagnosis of Alcohol or Other Drug Abuse or Dependence 2. Positive screen for alcohol abuse as determined by the CAGE questionnaire 3. Positive urine toxicity screen for benzodiazepine medications or illicit drugs 4. History of long-term use of benzodiazepine medications 5. Current use of non-benzodiazepine agonist medications 6. History of Panic Disorder 7. History of any Psychotic Disorder 8. History of seizures and/or Seizure Disorder 9. History of dysrhythmia, cardiovascular collapse, or recent head trauma 10. History of side effects from anticholinergic medications 11. History of cyclic antidepressant overdose or poisoning 12. Pregnant or nursing 13. Resides in nursing home or other long-term care facility

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hepatic Encephalopathy

Liver Cirrhosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:FlumazenilA priming dose bolus of 0.4 mg of flumazenil will be administered intravenously (Minute 0). At this time the 1H-MRS scan will begin. Over the next 6 minutes, a drip infusion of placebo mixed with saline will be administered to the patient at a rate of 0.1 mg per minute for a total of 7 doses during the scan. Total dose will be 1.0 mg.

Drug:PlaceboA priming dose bolus of 0.4 mg of placebo will be administered intravenously (Minute 0). At this time the 1H-MRS scan will begin. Over the next 6 minutes, a drip infusion of placebo mixed with saline will be administered to the patient at a rate of 0.1 mg per minute for a total of 7 doses during the scan. Total dose will be 1.0 mg.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

FlumazenilA priming dose bolus of 0.4 mg of flumazenil will be administered intravenously (Minute 0). At this time the 1H-MRS scan will begin. Over the next 6 minutes, a drip infusion of flumazenil will be administered to the patient at a rate of 0.1 mg flumazenil per minute for a total of 7 doses during the scan. Total dose will be 1.0 mg.

SalineA priming dose bolus of 0.4 mg of placebo will be administered intravenously (Minute 0). At this time the 1H-MRS scan will begin. Over the next 6 minutes, a drip infusion of placebo mixed with saline will be administered to the patient at a rate of 0.1 mg per minute for a total of 7 doses during the scan. Total dose will be 1.0 mg.

Study Status

Withdrawn

Start Date: June 2014

Completed Date: October 2017

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: hepatic encephalopathy symptoms

Secondary Outcome: hepatic encephalopathy symptoms

Study sponsors, principal investigator, and references

Principal Investigator: Hochang B Lee, MD

Lead Sponsor: Yale University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02048969

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