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Diagnosis of Covert/Minimal Hepatic Encephalopathy by Means of Continuous Reaction Time Measurement

NCT01773538 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2016-02-23

No results posted yet for this study

Summary

The investigators wish to investigate how the Continuous Reaction Time (CRT) method can be used in the diagnosis and monitoring of covert hepatic encephalopathy (cHE)in patients with cirrhosis of the liver. The hypothesis is that the CRT method (duration 10-2 minutes) can serve as a tool in the diagnosis and monitoring of cHE and is an alternative to using the Portosystemic Encephalopathy Test (PSE)(duration 20-25 minutes).

Conditions

Interventions

DRUG

Lactulose and rifaximin

3 months treatment. lactulose 25 Ml x3 per day. Rifaximin (550 mg) x 2 per day.

DIETARY_SUPPLEMENT

Branched Chain amino acids

30 grams of branched chain amino acids (Bramino) per day is given to the patients in the antiHE treatment arm along with lactulose and rifaximin.

OTHER

Placebo

Patients in the placebo-arm receives both placebo-Bramino, placebo-lactulose and placebo-rifaximin.

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER

  • Mette Munk Lauridsen

    lead OTHER

Principal Investigators

  • Ove Schaffalitzky de Muckadell, Professor · Odense University Hospital

  • Jeppe Gram, PhD, MD · Esbjerg Hospital - University Hospital of Southern Denmark

  • Hendrik Vilstrup, Professor · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-10-31
Completion
2015-11-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

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 NCT01773538 on ClinicalTrials.gov