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Study population: A total of 90 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences with SBP with septic shock will be included.
Study design: Randomized controlled trial Study period: August 2019 to December 2021. Sample size: Assuming that the response rate is 90% with GM-CSF and 60% without GM-CSF after day 5. With alpha 5 and power 80,we need to enroll 76 cases (38 cases with each). Further assuming 20 % drop-out due to various reasons, it was decided to enroll 90 cases randomly allocated into two groups (i.e., 45 in each) by block randomization method by taking block size as 6. So for the present study, it was decided to enroll 90 cases in all.
Group A will be given Imipenem and Tigecycline. Patients with recent hospitalisation will be given Colistin in addition.
Group B will be given: To another group we will give Imipenem and Tigecycline and GMCSF.Patients with recent hospitalisation will be given Colistin in addition.
The dose of antibiotic will be given at dosage Inj Imipenem 1gm i.v. TDS Inj Tigecycline 100mg stat f/b 50mg i.v. OD Inj GM-CSF 500mcg s.c. OD Inj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD Monitoring and assessment At the baseline, all patients will undergo investigational evaluation as described
Daily monitoring of following parameters:
Stopping rule:If the patient develops a TLC of more than 50,000, the dose of the GM CSF will be reduced to half and the treatment continued. If, even after the reduction, the TLC rises to more than 50,000, then the treatment will be stopped and the patient excluded.
Expected outcome of the project: Addition of GM-CSF to standard antibiotic regimen helps resolve SBP and improves outcome in decompensated liver cirrhotic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imipenem+Tigecycline+GM-CSF | Experimental |
| |
| Imipenem+Tigecycline | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imipenem | Drug | Inj Imipenem 1gm i.v. TDS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Spontaneous Bacterial peritonitis in both groups | Response is defined by resolution of SBP in terms of total counts < 500,Neutrophil<250 | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Reversal of shock in both groups | Blood pressure more than 90/60 mmHg with no inotropes requirement | Day 2 |
| Survival in both groups | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Abhijeet Ranjan, MD | Contact | 01146300000 | drkmrabhijeet@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Tigecycline | Drug | Inj Tigecycline 100mg stat f/b 50mg i.v. OD |
|
| GMCSF | Drug | Inj GM-CSF 500mcg s.c. OD |
|
| Colistin | Drug | Inj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD |
|
| Survival in both groups | Day 28 |
| Change in ascitic fluid metabolites Nitric Oxide in both groups | change is defined as percentage reduction in nitric oxide | Day 28 |
| Change in ascitic fluid macrophage population in both groups | change is defined as percentage reduction in macrophage population | Day 28 |
| Development of Hepatic Encephalopathy in both groups. | Hepatic Encephalopathy will be measured as per West Haven criteria | Day 28 |
| Development of Acute Kidney Injury in both groups | AKIN criteria will be used for Acute kidney injury | Day 28 |
| Development of Pneumonia in both groups. | Pneumonia will be confirmed based on imaging and clinically | Day 28 |
| Development of organ failures in both groups. | Organ failure will be as per APACHE score | Day 28 |
| Development of coagulopathy in both groups. | Coagulopathy is defined as INR > 1.5 | Day 28 |
| Resolution of Spontaneous Bacterial peritonitis in both groups | Response is defined by resolution of SBP in terms of total counts < 500,Neutrophil<250 | Day 2 |
| ID | Term |
|---|---|
| D015378 | Imipenem |
| D000078304 | Tigecycline |
| D003091 | Colistin |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
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