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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.

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ClinicalTrials.gov Identifier: NCT04208763
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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.


Condition or disease Intervention/treatment Phase
Spontaneous Bacterial Peritonitis Drug: Imipenem Drug: Tigecycline Drug: GMCSF Drug: Colistin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Imipenem and Tigecycline Versus Imipenem and Tigecycline With GM-CSF for the Management of Spontaneous Bacterial Peritonitis Presenting With Septic Shock.
Actual Study Start Date : December 20, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Imipenem+Tigecycline+GM-CSF Drug: Imipenem
Inj Imipenem 1gm i.v. TDS

Drug: Tigecycline
Inj Tigecycline 100mg stat f/b 50mg i.v. OD

Drug: GMCSF
Inj GM-CSF 500mcg s.c. OD

Drug: Colistin
Inj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD

Active Comparator: Imipenem+Tigecycline Drug: Imipenem
Inj Imipenem 1gm i.v. TDS

Drug: Tigecycline
Inj Tigecycline 100mg stat f/b 50mg i.v. OD

Drug: Colistin
Inj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD




Primary Outcome Measures :
  1. Resolution of Spontaneous Bacterial peritonitis in both groups [ Time Frame: Day 5 ]
    Response is defined by resolution of SBP in terms of total counts < 500,Neutrophil<250


Secondary Outcome Measures :
  1. Reversal of shock in both groups [ Time Frame: Day 2 ]
    Blood pressure more than 90/60 mmHg with no inotropes requirement

  2. Survival in both groups [ Time Frame: Day 7 ]
  3. Survival in both groups [ Time Frame: Day 28 ]
  4. Change in ascitic fluid metabolites Nitric Oxide in both groups [ Time Frame: Day 28 ]
    change is defined as percentage reduction in nitric oxide

  5. Change in ascitic fluid macrophage population in both groups [ Time Frame: Day 28 ]
    change is defined as percentage reduction in macrophage population

  6. Development of Hepatic Encephalopathy in both groups. [ Time Frame: Day 28 ]
    Hepatic Encephalopathy will be measured as per West Haven criteria

  7. Development of Acute Kidney Injury in both groups [ Time Frame: Day 28 ]
    AKIN criteria will be used for Acute kidney injury

  8. Development of Pneumonia in both groups. [ Time Frame: Day 28 ]
    Pneumonia will be confirmed based on imaging and clinically

  9. Development of organ failures in both groups. [ Time Frame: Day 28 ]
    Organ failure will be as per APACHE score

  10. Development of coagulopathy in both groups. [ Time Frame: Day 28 ]
    Coagulopathy is defined as INR > 1.5

  11. Resolution of Spontaneous Bacterial peritonitis in both groups [ Time Frame: Day 2 ]
    Response is defined by resolution of SBP in terms of total counts < 500,Neutrophil<250



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208763


Contacts
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Contact: Dr Abhijeet Ranjan, MD 01146300000 drkmrabhijeet@gmail.com

Locations
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India
Institute of Liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Abhijeet Ranjan, MD    01146300000    drkmrabhijeet@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT04208763    
Other Study ID Numbers: ILBS-SBP-02
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peritonitis
Infection
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases
Imipenem
Colistin
Tigecycline
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action