Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure
|ClinicalTrials.gov Identifier: NCT01852630|
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : November 22, 2016
- 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).
|Condition or disease||Intervention/treatment|
|Spontaneous Bacterial Peritonitis||Drug: cefepime + Albumin Drug: Imipenem + Albumin|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||December 2012|
|Primary Completion Date :||December 2015|
|Study Completion Date :||December 2015|
Experimental: cefepime + Albumin
cefepime 1g iv 8 hourly + Albumin will be given for 2 days.
Drug: Imipenem + Albumin
Imipenem + Albumin will be given for 2 days.
Active Comparator: Imipenem + Albumin
Imipenem 1g iv 8 hourly + Albumin will be given for 2 days.
Drug: cefepime + Albumin
cefepime + Albumin will be given for 2 days
- 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 ]
- Survival [ Time Frame: 15 days,1 month and 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852630
|Institute of Liver & Biliary Sciences (ILBS)|
|New Delhi, Delhi, India, 110070|
|Principal Investigator:||Dr Ankur Jindal, MD||Institute of Liver & Biliary Sciences (ILBS)|