A Randomized Controlled Trial Comparing Imipenem and Tigecycline Versus Imipenem and Tigecycline With GM-CSF for the Management of Spontaneous Bacterial Peritonitis Presenting With Septic Shock.

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Spontaneous Bacterial Peritonitis

Treatments: Drug: GMCSF; Drug: Imipenem; Drug: Tigecycline; Drug: Colistin

Study type: Interventional

Funder types: Other

Identifiers

NCT04208763

ILBS-SBP-02

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Imipenem+Tigecycline+GM-CSF

Experimental group

Treatment:

Drug: GMCSF

Drug: Colistin

Drug: Imipenem

Drug: Tigecycline

Imipenem+Tigecycline

Active Comparator group

Treatment:

Drug: Colistin

Drug: Imipenem

Drug: Tigecycline