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

• Status: Completed
• Trial end date: 2017-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Sargramostim

Criteria

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