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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbepenem+albumin+GMCSF. | Experimental |
| |
| Carbepenem+albumin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbepenem | Drug |
| ||
| Albumin |
| Measure | Description | Time Frame |
|---|---|---|
| Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis) | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at week 2 | week 2 | |
| Survival at week 4 | week 4 | |
| Survival at week 12 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vikash Prakash, MD | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Drug |
|
| GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) . | Drug |
|
| 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 |
| ID | Term |
|---|---|
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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