Effectiveness of Imipenem (drug) and Tigecycline (drug) Versus Imipenem and Tigecycline With GM-CSF (drug) for liver disease.
Not Applicable
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2019/12/022516
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Spontaneous Bacterial Peritonitis (SBP) with shock in a cirrhotic
2) Hospital acquired SBP with shock
3) Difficult to treat SBP
Exclusion Criteria
1) Refractory Shock
2) Cardiac comorbidities (known Coronary Artery Disease)
3) Chronic Kidney Disease on Maintenance Hemodialysis
4) < 18 years.
5) Advanced Hepatocellular Carcinoma
6) Post liver transplant
7) HIV + ve, Immunosuppressive therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Resolution of Spontaneous Bacterial peritonitisTimepoint: Day 5
- Secondary Outcome Measures
Name Time Method Change in ascitic fluid metabolites NO, macrophage population in both groupsTimepoint: Day 28;Development of Acute Kidney Injury in both groups <br/ ><br>Timepoint: Day 28;Development of coagulopathy in both groups. <br/ ><br>Timepoint: Day 28;Development of Hepatic Encephalopathy in both groups. <br/ ><br>Timepoint: Day 28;Development of organ failures in both groups. <br/ ><br>Timepoint: Day 28;Development of Pneumonia in both groups. <br/ ><br>Timepoint: Day 28;Response of SBP in ascitic fluid in both groupsTimepoint: Day 5;Response of Spontaneous Bacterial Peritonitis in ascitic fluid in both groupsTimepoint: Day 2;Reversal of shockTimepoint: Day 2;SurvivalTimepoint: Day 7 and day 28