Clinical Trial: To Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomized Study to Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis
Brief Summary:
A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to treat SBP will be included and randomized into two treatment groups.
Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF.
Detailed Summary:
Sponsor: Institute of Liver and Biliary Sciences, India
Current Primary Outcome: Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis) [ Time Frame: 1 week ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Survival at week 2 [ Time Frame: week 2 ]
- Survival at week 4 [ Time Frame: week 4 ]
- Survival at week 12 [ Time Frame: week 12 ]
- Total number of patients develop variceal bleed. [ Time Frame: 1 week ]
- Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment. [ Time Frame: 1 week ]
- Total number of patients develop HE (Hepatic Encephalopathy). [ Time Frame: 1 week ]
- Total number of patients develop AKI (Acute kidney Injury). [ Time Frame: 1 week ]
Original Secondary Outcome: Same as current
Information By: Institute of Liver and Biliary Sciences, India
Dates:
Date Received: May 22, 2015
Date Started: May 2015
Date Completion: May 2017
Last Updated: January 1, 2017
Last Verified: January 2017
