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

Primary Purpose

Acute Liver Failure, Acute on Chronic Liver Failure

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Methacetin Breath Test in ACLF and ALF patients
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Liver Failure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Liver & Biliary Sciences

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

ACLF and Acute Liver Failure (ALF)..

Arm Description

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).

Outcomes

Primary Outcome Measures

Survival or Transplantation for Acute Liver Failure (ALF).

Secondary Outcome Measures

Mortality or Transplantation for Acute on Chronic Liver Failure (ACLF) patients.

Full Information

First Posted
August 22, 2013
Last Updated
September 26, 2015
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT01946360
Brief Title
Role of 13C Methacetin Breath Test in Predicting Prognosis Among Patients With Acute or Acute on Chronic Liver Failure (ACLF).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Liver Failure, Acute on Chronic Liver Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACLF and Acute Liver Failure (ALF)..
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Methacetin Breath Test in ACLF and ALF patients
Intervention Description
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).
Primary Outcome Measure Information:
Title
Survival or Transplantation for Acute Liver Failure (ALF).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Mortality or Transplantation for Acute on Chronic Liver Failure (ACLF) patients.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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. Patients with previous intestinal bypass surgery for morbid obesity Patients with extensive small bowel resection Patients currently receiving total parenteral nutrition Pregnant women Patients with history of allergy to paracetamol Patients on steroids or anti-fungal agents Patients in encephalopathy Patients unwilling to participate in the protocol Patients on medications which can alter the activity of CYP 1A2 enzymes such as corticosteroids, amiodarone, tetracycline, niacin, valproic acid, methotrexate, stavudine and zidovudine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Ashok Choudhary, DM
Organizational Affiliation
Institute of Liver & Biliary Sciences.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

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

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