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Study on outcomes of serious antibiotic resistant infections in sepsis patients with and without liver cirrhosis in the ICU

Comparison of mortality in carbapenem resistant gram negative infections in sepsis patients with or without liver cirrhosis: A prospective observational study - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/03/105291
Enrollment
70
Registered
2026-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Dr Aditya Parashar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age: Adult patients (18 years). Diagnosis: Sepsis, defined according to Sepsis-3 criteria. Microbiological confirmation: Presence of carbapenem-resistant Gram-negative (CRGN) infections. Source of isolates: Confirmed from blood cultures or samples obtained from other sterile sites, including: Ascitic fluid Cerebrospinal fluid Urine Respiratory secretions

Exclusion criteria

Exclusion criteria: 1) Patients with solid organ transplants other than liver within six months 2) Patients with primary immunodeficiency disorders 3) Patients with HIV infection 4) Patients with who decline consent 5) Patients with CRGN colonization without active infection

Design outcomes

Primary

MeasureTime frame
30-day all-cause mortality among sepsis patients infected with carbapenem-resistant gram-negative (CRGN) organisms, compared between those with and without liver cirrhosis.Timepoint: 30-days from culture positive date

Secondary

MeasureTime frame
1)Identification & comparison of risk factors associated with CRGN infections in cirrhotic & non-cirrhotic patients (age, comorbidities, prior hospitalization, recent antibiotic exposure, nutritional status, & septic shock at presentation) . Timepoint: baseline on admission in icu;Detection & comparison of molecular mechanisms of carbapenem resistance (carbapenemase genes: KPC, NDM, VIM, OXA-48, IMP) between groupsTimepoint: During ICU stay;Evaluation of organ dysfunction related outcomes including 1.Development of acute kidney injury & requirement for renal replacement therapy 2.Need for invasive mechanical ventilation & duration of mechanical ventilation 3.Development of septic shock Timepoint: During ICU stay;Comparison of healthcare utilization outcomes 1.Duration of ICU stay 2.Total hospital length of stay Timepoint: During total Hospital stay;Comparison of antimicrobial susceptibility patterns of CRGN isolates between cirrhotic & non-cirrhotic patientsTimepoint: During total Hospital stay

Countries

India

Contacts

Public ContactAditya Parashar

Amrita School of Medicine

Aayush.chawla@fbd.amrita.edu9811766334

Outcome results

None listed

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