NCT01946360

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

August 22, 2013

Last Update Submit

September 26, 2015

Conditions

Acute Liver FailureAcute on Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

  • Survival or Transplantation for Acute Liver Failure (ALF).

    2 years

Secondary Outcomes (1)

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

    12 weeks

Study Arms (1)

ACLF and Acute Liver Failure (ALF)..

NO INTERVENTION

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

Interventions

Methacetin Breath Test in ACLF and ALF patientsDEVICE

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).

ACLF and Acute Liver Failure (ALF)..

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Failure, AcuteAcute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Dr Ashok Choudhary, DM

    Institute of Liver & Biliary Sciences.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2013

First Posted

September 19, 2013

Study Start

April 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

IN(1)