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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02573727
Other study ID # ILBS-ACLF-004
Secondary ID
Status Completed
Phase N/A
First received October 5, 2015
Last updated November 14, 2017
Start date October 2015
Est. completion date January 2017

Study information

Verified date July 2016
Source Institute of Liver and Biliary Sciences, India
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Continous infusion of nor adrenaline + albumin Continous infusion of terlipressin + albumin Response will assessed at every 48 hour (i) Complete response: Regression of acute kidney injury stage with reduction of S. Cr within 0.3 mg/dl of baseline (ii) Partial response: Regression of acute kidney injury stage with reduction of S. Cr to ≥0.3 mg/dl above baseline (iii) No response: No regression of acute kidney injury

Treatment will be extended until reversal of HRS (decrease in creatinine below 1.5 mg/dL) or for a maximum of 7 days after rescue treatment will be followed.

If intolerant to terlipressin, excluded from study and rescue treatment will be given in form of noradrenaline or octreotide and midodrine.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Patients with acute on chronic liver failure presenting with hepatorenal syndrome

2. Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria:

1. Age less than 18 years

2. Decompensated cirrhotics

3. Evidence of chronic kidney disease

4. Patients undergoing renal replacement therapy (hemo-dialysis/renal transplantation).

5. Post liver transplantation patients.

6. History of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease.

7. Patients with obstructive uropathy.

8. Patient who withdrew or non complaint to the study protocol.

Study Design


Intervention

Drug:
Nor adrenaline + albumin

Terlipressin + albumin


Locations

Country Name City State
India Institute of liver and 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 Response to treatment in each intervention group Complete response: Regression of acute kidney injury stage with reduction of S. Cr within 0.3 mg/dl of baseline (ii) Partial response: Regression of acute kidney injury stage with reduction of S. Cr to =0.3 mg/dl above baseline (iii) No response: No regression of acute kidney injury. 14 days
Secondary Survival 28 days
Secondary Drug related Side effects/complications 28 days
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