Clinical Trial: Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Comparative Open Label Study of Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure.
Brief Summary:
- All consecutive patients with Cirrhosis and ascites admitted to ILBS (Institute of Liver & Biliary Sciences) will be evaluated for the presence of SBP (Spontaneous Bacterial Peritonitis) by ascitic fluid examination at admission.
- SBP (Spontaneous Bacterial Peritonitis) will be diagnosed in the presence of absolute neutrophil count (ANC >250/mm3) with/without positive ascitic fluid culture and Patients with SBP (Spontaneous Bacterial Peritonitis) included in the study will be randomized to receive cefepime or imipenem.
- However, other SBP (Spontaneous Bacterial Peritonitis) patients not included for randomization will be given empirical therapy with 3rd generation cephalosporin (ceftriaxone).
Detailed Summary:
Baseline evaluation:
Baseline clinical, laboratory and disease severity parameters will be evaluated for each study patient.
- Etiology of cirrhosis.
- Severity of liver disease. CTP (Child-Turcotte-Pugh) score MELD (Model for End-stage Liver Disease) score MELD (Model for End-stage Liver Disease)-Na score IMSAA score
- Decompensations/complications of CLD (Chronic Liver Disease) UGI bleed, Hepatic encephalopathy, AKI (Acute Kidney Injury) etc.
- Laboratory investigations:
Serum electrolytes Liver function tests Kidney function tests Pro calcitonin USG/CT abdomen Complete blood counts Coagulation parameters Ascitic fluid analysis- TLC, DLC, Protein, sugar, culture, SAAG. Chest X ray PA view HBsAg and Anti-HCV and other etiological workup as available.
Sponsor: Institute of Liver and Biliary Sciences, India
Current Primary Outcome: The primary outcome of the study is the Response to treatment in each intervention group. Response is defined as 25% reduction in ANC (Absolute Neutrophil Count) from baseline. [ Time Frame: 2 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Survival [ Time Frame: 15 days,1 month and 3 months ]
Original Secondary Outcome: Same as current
Information By: Institute of Liver and Biliary Sciences, India
Dates:
Date Received: December 6, 2012
Date Started: December 2012
Date Completion:
Last Updated: November 21, 2016
Last Verified: July 2016