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:

  1. 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.
  2. 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.
  3. 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.

  1. Etiology of cirrhosis.
  2. 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
  3. Decompensations/complications of CLD (Chronic Liver Disease) UGI bleed, Hepatic encephalopathy, AKI (Acute Kidney Injury) etc.
  4. 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