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

Not Applicable

Completed

• Conditions: Spontaneous Bacterial Peritonitis
• Interventions: Drug: Carbepenem; Drug: Albumin; Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .

• Registration Number: NCT02468089
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-10
• Status Verified: 2017-01
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbepenem+albumin+GMCSF.	Carbepenem	-
Carbepenem+albumin+GMCSF.	Albumin	-
Carbepenem+albumin+GMCSF.	GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .	-
Carbepenem+albumin	Carbepenem	-
Carbepenem+albumin	Albumin	-

Primary Outcome Measures

Name	Time	Method
Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis)	1 week

Secondary Outcome Measures

Name	Time	Method
Survival at week 2	week 2
Survival at week 4	week 4
Survival at week 12	week 12
Total number of patients develop variceal bleed.	1 week
Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment.	1 week
Total number of patients develop HE (Hepatic Encephalopathy).	1 week
Total number of patients develop AKI (Acute kidney Injury).	1 week

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India