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

NCT01773538 | Completed DMC

• 1 other identifier: CHECRT
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

Brief 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

Liver Cirrhosis; Hepatic Encephalopathy

Keywords

quality of life

Outcome Measures

Primary Outcomes (1)

• Change in Continuous Reaction Time Method versus Portosystemic Encephalopathy Test

  The investigators are evaluating if the CRT and PSE test are in accordance at inclusion and after 3 months of treatment.

  baseline and 3 months

Secondary Outcomes (3)

• Change in Continuous Reaction Time Method versus Quality of Life (QoL)

  baseline and 3 months

• Correlation between CRT test and PSE test at inclusion

  at baseline

• Correlation between psychometric test results and quality of life af base line

  at base line

Other Outcomes (1)

• Danish normal values for the PSE test

  at base line

Study Arms (2)

Anti cHE treatment arm

ACTIVE COMPARATOR

Of 150 included patients aprox. 44 regardless of CRT and PSE test outcome will be offered to enter randomisation and 3 months follow up. Half of 44 patients will receive both lactulose, rifaximin and branched chain aminoacids (Bramino) the other half placebo.

Drug: Lactulose and rifaximin; Dietary Supplement: Branched Chain amino acids

Placebo arm

PLACEBO COMPARATOR

The goal of this intervention is to investigate whether the CRT method can detect an expected treatment response after initiation of the 3 named drugs know to ameliorate HE symptoms including psychometric test results.

Other: Placebo

Interventions

Lactulose and rifaximin DRUG

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

Anti cHE treatment arm

Branched Chain amino acids DIETARY_SUPPLEMENT

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.

Anti cHE treatment arm

Placebo OTHER

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

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For healthy volunteers:
• Age\> 18 years
• Written informed consent
• Speak and understand Danish
• For patients:
• Age \> 18 years
• Liver cirrhosis confirmed by biopsy or appropriate clinic and biochemistry, and imaging.
• Written informed consent
• Speak and understand Danish

You may not qualify if:

• Clinical manifest hepatic encephalopathy
• Consumption of psychoactive substances within 6 days of test
• Organic brain disease (i.e. prior stroke, dementia)
• Hypothyroidism
• Renal failure (creatinine\> 150 mg / dL)
• Hyponatremia (Na \<125 mmol / L)
• Sepsis or bleeding within one week prior to testing.
• Serious sleep disorders
• Current treatment with lactulose, rifaximin or BCAA

Sponsors & Collaborators

• Mette Munk Lauridsen: lead
• Region of Southern Denmark: collaborator
• Odense University Hospital: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator

Study Sites (2)

Hospital of South West Jutland

Esbjerg, 6700, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hepatic Encephalopathy

Interventions

Lactulose; Rifaximin; Amino Acids

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Amino Acids, Peptides, and Proteins

Study Officials

• Ove Schaffalitzky de Muckadell, Professor

  Odense University Hospital

  STUDY DIRECTOR

• Jeppe Gram, PhD, MD

  Esbjerg Hospital - University Hospital of Southern Denmark

  STUDY CHAIR

• Hendrik Vilstrup, Professor

  Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Phd student

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 23, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

DK (2)