Spontaneous Bacterial Peritonitis
Conditions
Brief summary
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: * Haemoglobin, * Total peripheral leucocyte counts, * Platelet counts, * Renal function tests * Liver function tests and * Chest X rays will be undertaken * Ascitic fluid analysis will be done on day 0, day 2 and day 5 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.
Interventions
DRUGImipenem
Inj Imipenem 1gm i.v. TDS
DRUGTigecycline
Inj Tigecycline 100mg stat f/b 50mg i.v. OD
DRUGGMCSF
Inj GM-CSF 500mcg s.c. OD
DRUGColistin
Inj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Spontaneous Bacterial Peritonitis (SBP) with shock in a cirrhotic 2. Hospital acquired SBP with shock 3. Difficult to treat SBP
Exclusion criteria
1. Refractory Shock 2. Cardiac comorbidities (known Coronary Artery Disease) 3. Chronic Kidney Disease on Maintenance Hemodialysis 4. \< 18 years. 5. Advanced Hepatocellular Carcinoma 6. Post liver transplant 7. HIV + ve, Immunosuppressive therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of Spontaneous Bacterial peritonitis in both groups | Day 5 | Response is defined by resolution of SBP in terms of total counts \< 500,Neutrophil\<250 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival in both groups | Day 7 | — |
| Change in ascitic fluid metabolites Nitric Oxide in both groups | Day 28 | change is defined as percentage reduction in nitric oxide |
| Change in ascitic fluid macrophage population in both groups | Day 28 | change is defined as percentage reduction in macrophage population |
| Development of Hepatic Encephalopathy in both groups. | Day 28 | Hepatic Encephalopathy will be measured as per West Haven criteria |
| Reversal of shock in both groups | Day 2 | Blood pressure more than 90/60 mmHg with no inotropes requirement |
| Development of Pneumonia in both groups. | Day 28 | Pneumonia will be confirmed based on imaging and clinically |
| Development of organ failures in both groups. | Day 28 | Organ failure will be as per APACHE score |
| Development of coagulopathy in both groups. | Day 28 | Coagulopathy is defined as INR \> 1.5 |
| Resolution of Spontaneous Bacterial peritonitis in both groups | Day 2 | Response is defined by resolution of SBP in terms of total counts \< 500,Neutrophil\<250 |
| Development of Acute Kidney Injury in both groups | Day 28 | AKIN criteria will be used for Acute kidney injury |
Countries
India
Contacts
Primary ContactDr Abhijeet Ranjan, MD
Outcome results
None listed