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:
- Complete response: Decrease in serum creatinine to 133 lmol/L (1.5 mg/dL).
- Partial response: 50% serum creatinine decrease from baseline to a final value >133 lmol/L (>1.5 mg/dL).
- 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