To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure

Acute on Chronic Liver Failure Clinical Trial

Official title:

''To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure'

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573727
• Other study ID #: ILBS-ACLF-004
• 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
• 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.

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatorenal Syndrome
• Liver Failure

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