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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01946360
Other study ID # ILBS-ACLF-MBT-01
Secondary ID
Status Completed
Phase N/A
First received August 22, 2013
Last updated September 26, 2015
Start date April 2014
Est. completion date January 2015

Study information

Verified date September 2015
Source Institute of Liver and Biliary Sciences, India
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

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).

Locations

Country Name City State
India Institute of Liver & Biliary Sciences New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival or Transplantation for Acute Liver Failure (ALF). 2 years Yes
Secondary Mortality or Transplantation for Acute on Chronic Liver Failure (ACLF) patients. 12 weeks Yes
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