Role of 13C Methacetin Breath Test in Predicting Prognosis Among Patients With Acute or Acute on Chronic Liver Failure (ACLF).

September 26, 2015 updated by: Institute of Liver and Biliary Sciences, India

Blood will be collected after venepuncture from all patients for complete blood counts, Serum bilirubin (direct and indirect), aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, prothrombin time and INR, urea, creatinine, sodium, potassium, serum total protein and albumin, within 24 hours after admission and twice a week there after or as and when needed.

Time line for blood tests and evaluation of clinical parameters & 13C-MBT

For ALF patients:

On days 0, 1, 3, and 7

For ACLF patients:

On days 0, 7 (week 1), 14(week 2), 28 (weeks 4)

Blood tests would include:

Serum bilirubin (total and direct), aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyltransferase, Serum proteins (total and albumin), prothrombin time & international normalized ratio (INR), Serum urea and creatinine, serum electrolytes, arterial ammonia and arterial blood gas analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of Liver & Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- All patients presenting with acute liver failure and acute on chronic liver failure (between 18 - 70 years of age) to Institute of Liver & Biliary Sciences (ILBS), New Delhi, India.

Exclusion Criteria:

  1. Patients with significant co-morbid illnesses such as cardiovascular or respiratory or intrinsic renal diseases which by themselves may have a bearing on the outcome.
  2. Patients with previous intestinal bypass surgery for morbid obesity
  3. Patients with extensive small bowel resection
  4. Patients currently receiving total parenteral nutrition
  5. Pregnant women
  6. Patients with history of allergy to paracetamol
  7. Patients on steroids or anti-fungal agents
  8. Patients in encephalopathy
  9. Patients unwilling to participate in the protocol
  10. Patients on medications which can alter the activity of CYP 1A2 enzymes such as corticosteroids, amiodarone, tetracycline, niacin, valproic acid, methotrexate, stavudine and zidovudine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: ACLF and Acute Liver Failure (ALF)..
Methacetin Breath Test will be done on Day 0,7,14,28 in Acute on Chronic Liver Failure (ACLF)and on day 0,1,3,7 in Acute Liver failure (ALF).
Device: Methacetin Breath Test in ACLF and ALF patients
Methacetin Breath Test will be done on Day 0,7,14,28 in Acute on Chronic Liver Failure (ACLF)and on day 0,1,3,7 in Acute Liver failure (ALF).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival or Transplantation for Acute Liver Failure (ALF).
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality or Transplantation for Acute on Chronic Liver Failure (ACLF) patients.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Principal Investigator: Dr Ashok Choudhary, DM, Institute of Liver & Biliary Sciences.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 19, 2013

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 26, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-ACLF-MBT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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