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.

Spontaneous Bacterial Peritonitis Clinical Trial

Official title:

Imipenem and Tigecycline Versus Imipenem and Tigecycline With GM-CSF for the Management of Spontaneous Bacterial Peritonitis Presenting With Septic Shock.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04208763
• Other study ID #: ILBS-SBP-02
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Abhijeet Ranjan, MD
• Phone: 01146300000
• Email: drkmrabhijeet[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peritonitis
• Spontaneous Bacterial Peritonitis

Intervention

Drug:
• Imipenem
Inj Imipenem 1gm i.v. TDS
• Tigecycline
Inj Tigecycline 100mg stat f/b 50mg i.v. OD
• GMCSF
Inj GM-CSF 500mcg s.c. OD
• Colistin
Inj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Reversal of shock in both groups	Blood pressure more than 90/60 mmHg with no inotropes requirement	Day 2
Secondary	Survival in both groups		Day 7
Secondary	Survival in both groups		Day 28
Secondary	Change in ascitic fluid metabolites Nitric Oxide in both groups	change is defined as percentage reduction in nitric oxide	Day 28
Secondary	Change in ascitic fluid macrophage population in both groups	change is defined as percentage reduction in macrophage population	Day 28
Secondary	Development of Hepatic Encephalopathy in both groups.	Hepatic Encephalopathy will be measured as per West Haven criteria	Day 28
Secondary	Development of Acute Kidney Injury in both groups	AKIN criteria will be used for Acute kidney injury	Day 28
Secondary	Development of Pneumonia in both groups.	Pneumonia will be confirmed based on imaging and clinically	Day 28
Secondary	Development of organ failures in both groups.	Organ failure will be as per APACHE score	Day 28
Secondary	Development of coagulopathy in both groups.	Coagulopathy is defined as INR > 1.5	Day 28
Secondary	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