Ankur Jindal1, Manoj Kumar1, Ajeet S Bhadoria2, Rakhi Maiwall1, Shiv K Sarin1,3. 1. Department of Hepatology, Institute of Liver & Biliary Sciences (ILBS), New Delhi, India. 2. Department of epidemiology and clinical research, Institute of Liver & Biliary Sciences (ILBS), New Delhi, India. 3. Special Centre for Molecular Medicine, Jawaharlal Nehru University (JNU), New Delhi, India.
Abstract
BACKGROUND & AIMS:Spontaneous bacterial peritonitis (SBP), in the presence of bacterial resistance or failure of third generation cephalosporins (3rd GC) has poor outcome. Empirical antibiotic(s) options are limited in these scenarios. METHODS:Consecutive cirrhotics with SBP because of hospital acquired SBP (>48 h of admission), microbial resistance or non-response (no resolution of SBP at 48 h) were randomized to Cefepime (n = 88) orImipenem (n = 87) plus standard medical therapy. We assessed for 'response at 48 h' (reduction in ascitic fluid absolute neutrophil count (ANC) by >25% at 48 h), resolution of SBP (<250 cu/mm ANC at day 5) and their clinical outcome. RESULTS:Of 957 paracentesis in 1200 hospitalized cirrhotics, 253 (26.4%) had SBP and 175 (69.6%) were randomized. Baseline parameters were comparable in two groups. Response at 48 h (58.6% vs. 51.7%; P = 0.4) and resolution of SBP in those with response at 48 h were comparable with no difference in mortality at week 2, month 1 and 3. Patients with 'No response at 48 h' had higher mortality compared with responders (73.8% vs. 25%; P < 0.001). Resolution of SBP was associated with 'response at 48 h' and septic shock, latter being main pre-terminal event. AKI at enrolment [Hazard ratio (HR), 2.6], pneumonia [HR, 2.9], septic shock [HR, 2.2] and response at 48 h [HR, 4.6] predicted poor outcome. CONCLUSIONS: In hospitalized cirrhotics with SBP and risk factors for treatment failure, cefepime showed comparable efficacy and survival to imipenem. Non-response to therapy at 48 h is a reliable predictor of treatment failure and mortality. Antibiotic combinations and novel options are needed for these patients.
RCT Entities:
BACKGROUND & AIMS: Spontaneous bacterial peritonitis (SBP), in the presence of bacterial resistance or failure of third generation cephalosporins (3rd GC) has poor outcome. Empirical antibiotic(s) options are limited in these scenarios. METHODS: Consecutive cirrhotics with SBP because of hospital acquired SBP (>48 h of admission), microbial resistance or non-response (no resolution of SBP at 48 h) were randomized to Cefepime (n = 88) or Imipenem (n = 87) plus standard medical therapy. We assessed for 'response at 48 h' (reduction in ascitic fluid absolute neutrophil count (ANC) by >25% at 48 h), resolution of SBP (<250 cu/mm ANC at day 5) and their clinical outcome. RESULTS: Of 957 paracentesis in 1200 hospitalized cirrhotics, 253 (26.4%) had SBP and 175 (69.6%) were randomized. Baseline parameters were comparable in two groups. Response at 48 h (58.6% vs. 51.7%; P = 0.4) and resolution of SBP in those with response at 48 h were comparable with no difference in mortality at week 2, month 1 and 3. Patients with 'No response at 48 h' had higher mortality compared with responders (73.8% vs. 25%; P < 0.001). Resolution of SBP was associated with 'response at 48 h' and septic shock, latter being main pre-terminal event. AKI at enrolment [Hazard ratio (HR), 2.6], pneumonia [HR, 2.9], septic shock [HR, 2.2] and response at 48 h [HR, 4.6] predicted poor outcome. CONCLUSIONS: In hospitalized cirrhotics with SBP and risk factors for treatment failure, cefepime showed comparable efficacy and survival to imipenem. Non-response to therapy at 48 h is a reliable predictor of treatment failure and mortality. Antibiotic combinations and novel options are needed for these patients.
Authors: Gayathri Vasanthakumari Sasidharan Nair; Prannoy George Mathen; M Gopalakrishna Pillai; K P Gireesh Kumar; K K Velayudhan; T P Sreekrishnan Journal: Int J Crit Illn Inj Sci Date: 2019-12-11
Authors: Laura Iogna Prat; Peter Wilson; Suzanne C Freeman; Alex J Sutton; Nicola J Cooper; Davide Roccarina; Amine Benmassaoud; Maria Corina Plaz Torres; Neil Hawkins; Maxine Cowlin; Elisabeth Jane Milne; Douglas Thorburn; Chavdar S Pavlov; Brian R Davidson; Emmanuel Tsochatzis; Kurinchi Selvan Gurusamy Journal: Cochrane Database Syst Rev Date: 2019-09-16