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Effectiveness of Imipenem (drug) and Tigecycline (drug) Versus Imipenem and Tigecycline With GM-CSF (drug) for liver disease.

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/12/022516
Enrollment
90
Registered
2019-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Imipenem,Tigecycline and 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:

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion 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

Exclusion criteria: 1) Refractory Shock 2) Cardiac comorbidities (known Coronary Artery Disease) 3) Chronic Kidney Disease on Maintenance Hemodialysis 4) 5) Advanced Hepatocellular Carcinoma 6) Post liver transplant 7) HIV + ve, Immunosuppressive therapy

Design outcomes

Primary

MeasureTime frame
Resolution of Spontaneous Bacterial peritonitisTimepoint: Day 5—

Secondary

MeasureTime frame
Change in ascitic fluid metabolites NO, macrophage population in both groupsTimepoint: Day 28;Development of Acute Kidney Injury in both groups Timepoint: Day 28;Development of coagulopathy in both groups. Timepoint: Day 28;Development of Hepatic Encephalopathy in both groups. Timepoint: Day 28;Development of organ failures in both groups. Timepoint: Day 28;Development of Pneumonia in both groups. Timepoint: Day 28;Response of SBP in ascitic fluid in both groupsTimepoint: Day 5;Response of Spontaneous Bacterial Peritonitis in ascitic fluid in both groupsTimepoint: Day 2;Reversal of shockTimepoint: Day 2;SurvivalTimepoint: Day 7 and day 28—

Countries

India

Contacts

Public ContactDr Abhijeet Ranjan

Institute of Liver and Biliary Sciences

shivsarin@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026