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Trial record 16 of 1399 for:    bilirubin AND alanine

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

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ClinicalTrials.gov Identifier: NCT01946360
Recruitment Status : Completed
First Posted : September 19, 2013
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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.


Condition or disease Intervention/treatment Phase
Acute Liver Failure Acute on Chronic Liver Failure Device: Methacetin Breath Test in ACLF and ALF patients Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : April 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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).




Primary Outcome Measures :
  1. Survival or Transplantation for Acute Liver Failure (ALF). [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Mortality or Transplantation for Acute on Chronic Liver Failure (ACLF) patients. [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946360


Locations
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India
Institute of Liver & Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
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Principal Investigator: Dr Ashok Choudhary, DM Institute of Liver & Biliary Sciences.

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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01946360     History of Changes
Other Study ID Numbers: ILBS-ACLF-MBT-01
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Failure, Acute
Liver Diseases
Digestive System Diseases