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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Study to Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis

Conditions
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Spontaneous Bacterial Peritonitis

Intervention / Treatment
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* Drug: Carbepenem
* Drug: Albumin
* Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 18 years 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: < 18 years. Advanced HCC (HepatoCellular Carcinoma) Post liver transplant HIV + ve, Immunosuppressive therapy Pregnancy Domiciliary treatment No consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbepenem+albumin+GMCSF.<br> | Drug: Carbepenem<br> <br> Drug: Albumin<br> <br> Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .<br> <br> |
| Active Comparator: Carbepenem+albumin<br> | Drug: Carbepenem<br> <br> Drug: Albumin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis) |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |