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Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure

NCT ID: NCT01852630

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-12-31

Brief Summary

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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 Description

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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.

Conditions

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Spontaneous Bacterial Peritonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cefepime + Albumin

cefepime 1g iv 8 hourly + Albumin will be given for 2 days.

Group Type EXPERIMENTAL

Imipenem + Albumin

Intervention Type DRUG

Imipenem + Albumin will be given for 2 days.

Imipenem + Albumin

Imipenem 1g iv 8 hourly + Albumin will be given for 2 days.

Group Type ACTIVE_COMPARATOR

cefepime + Albumin

Intervention Type DRUG

cefepime + Albumin will be given for 2 days

Interventions

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cefepime + Albumin

cefepime + Albumin will be given for 2 days

Intervention Type DRUG

Imipenem + Albumin

Imipenem + Albumin will be given for 2 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Cirrhotic Patients with SBP (Spontaneous Bacterial Peritonitis) having any of the following risk factors would be considered as 'Difficult to Treat SBP' and would be included -

1. Nosocomial SBP: occurence of SBP (Spontaneous Bacterial Peritonitis) after 48 hours of hospital admission, or
2. Prior ascitic fluid infection with 3rd generation cephalosporin resistant organism, or
3. No response to treatment with 3rd generation cephalosporins after 48 hours.

Exclusion Criteria

1. Age less than 18 years.
2. Cirrhotics with SBP (Spontaneous Bacterial Peritonitis) managed as outpatients.
3. Post liver transplant, HIV patients.
4. Patients on systemic chemotherapy, immunosuppressant drugs.
5. Growth of bacteria resistant to intervention drugs in ascitic fluid culture.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Ankur Jindal, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver & Biliary Sciences (ILBS)

Locations

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Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

References

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Jindal A, Kumar M, Bhadoria AS, Maiwall R, Sarin SK. A randomized open label study of 'imipenem vs. cefepime' in spontaneous bacterial peritonitis. Liver Int. 2016 May;36(5):677-87. doi: 10.1111/liv.12985. Epub 2015 Nov 21.

Reference Type DERIVED
PMID: 26474358 (View on PubMed)

Other Identifiers

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ILBS- SBP-01

Identifier Type: -

Identifier Source: org_study_id