To Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Spontaneous Bacterial Peritonitis

Treatments: Drug: Albumin; Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .; Drug: Carbepenem

Study type: Interventional

Funder types: Other

Identifiers

NCT02468089

ILBS-SBP-001

Details and patient eligibility

About

A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to treat SBP will be included and randomized into two treatment groups.

Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age more than 18 years

2. Patients of decompensated liver cirrhosis who present with- Spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascetic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that is not responding to initial therapy- DTT-SBP:

   • Hospital acquired - New onset SBP (Spontaneous bacterial peritonitis) after 48 h of hospitalization.
   • Recurrent SBP - One or more prior episode(s) of SBP in year.
   • Antibiotic resistant - Resistance to 3rd Gen Cephalosporin in last 3 m.
   • Antibiotic non-response -Non-response to 3rd Gen Cephalosporin, sepsis on 3rd Gen Cephalosporin.

Exclusion criteria

1. < 18 years.
2. Advanced HCC (HepatoCellular Carcinoma)
3. Post liver transplant
4. HIV + ve, Immunosuppressive therapy
5. Pregnancy
6. Domiciliary treatment
7. No consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Carbepenem+albumin+GMCSF.

Experimental group

Treatment:

Drug: Carbepenem

Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .

Drug: Albumin

Carbepenem+albumin

Active Comparator group

Treatment:

Drug: Carbepenem

Drug: Albumin