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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

Continous infusion of nor adrenaline + albumin Continous infusion of terlipressin + albumin Response will assessed at every 48 hour (i) Complete response: Decrease in serum creatinine to 133 lmol/L (1.5 mg/dL). (ii) Partial response: 50% serum creatinine decrease from baseline to a final value >133 lmol/L (>1.5 mg/dL).

(iii) No response: Serum creatinine decrease of < 50% from baseline

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.


Detailed Summary:
Sponsor: Institute of Liver and Biliary Sciences, India

Current Primary Outcome: Response to treatment in each intervention group [ Time Frame: 1 year ]

Response will assessed at every 48 hour:

  1. Complete response: Decrease in serum creatinine to 133 lmol/L (1.5 mg/dL).
  2. Partial response: 50% serum creatinine decrease from baseline to a final value >133 lmol/L (>1.5 mg/dL).
  3. No response: Serum creatinine decrease of < 50% from baseline


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Survival [ Time Frame: 7 days ]
  • Survival [ Time Frame: 28 months ]
  • Drug related Side effects/complications [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Institute of Liver and Biliary Sciences, India

Dates:
Date Received: October 5, 2015
Date Started: October 2015
Date Completion:
Last Updated: January 28, 2017
Last Verified: July 2016