| CTRI Number |
CTRI/2026/03/105291 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on outcomes of serious antibiotic resistant infections in sepsis patients with and without liver cirrhosis in the ICU |
|
Scientific Title of Study
|
Comparison of mortality in carbapenem resistant gram negative infections in sepsis patients with or without liver cirrhosis: A prospective observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Parashar |
| Designation |
DrNB Resident |
| Affiliation |
Amrita School of Medicine |
| Address |
Department of Critical Care Medicine
Amrita Hospital Faridabad Haryana sector 88 faridabad haryana Faridabad HARYANA 121002 India |
| Phone |
8608364438 |
| Fax |
|
| Email |
adityaparashar005@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Aayush chawla |
| Designation |
Senior consultant and assistant professor |
| Affiliation |
Amrita School of Medicine |
| Address |
Department of Critical Care Medicine
Amrita Hospital Faridabad Haryana sector 88 faridabad haryana Faridabad HARYANA 121002 India |
| Phone |
9811766334 |
| Fax |
|
| Email |
Aayush.chawla@fbd.amrita.edu |
|
Details of Contact Person Public Query
|
| Name |
Aditya Parashar |
| Designation |
DrNB Resident |
| Affiliation |
Amrita School of Medicine |
| Address |
Department of Critical Care Medicine
Amrita Hospital Faridabad Haryana sector 88 faridabad haryana Faridabad HARYANA 121002 India |
| Phone |
8608364438 |
| Fax |
|
| Email |
adityaparashar005@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aditya Parashar |
| Address |
Amrita Hospital Faridabad 121002 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aditya Parashar |
Amrita Hospital |
2nd Floor MICU Faridabad HARYANA |
08608364438
adityaparashar005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 30-day all-cause mortality among sepsis patients infected with carbapenem-resistant gram-negative (CRGN) organisms, compared between those with and without liver cirrhosis. |
30-days from culture positive date |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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) .
|
baseline on admission in icu |
| Detection & comparison of molecular mechanisms of carbapenem resistance (carbapenemase genes: KPC, NDM, VIM, OXA-48, IMP) between groups |
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
|
During ICU stay |
Comparison of healthcare utilization outcomes
1.Duration of ICU stay
2.Total hospital length of stay
|
During total Hospital stay |
| Comparison of antimicrobial susceptibility patterns of CRGN isolates between cirrhotic & non-cirrhotic patients |
During total Hospital stay |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="1" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Carbapenem-resistant gram-negative bacteria (CRGN) are increasingly recognized as critical pathogens causing severe infections, especially in critically ill patients with sepsis. These multidrug-resistant organisms, including species like Enterobacteriacea, Pseudomonas aeruginosa, and Acinetobacter baumannii, pose significant clinical challenges due to limited therapeutic options and high mortality rates. Sepsis caused by CRGN often leads to prolonged hospitalization, increased healthcare costs, and poor patient outcomes, making early identification and appropriate management vital. Patients with liver cirrhosis represent a particularly vulnerable population for CRGN infections. Cirrhosis induces systemic immunodeficiency and disrupts the gut-liver axis, promoting bacterial translocation and colonization by multidrug-resistant organisms. This immunocompromised state, coupled with frequent healthcare exposures such as hospital admissions, antibiotic treatments, and invasive procedures, substantially increases infection risk. Bacterial infections in cirrhotic patients frequently precipitate acute decompensation and acute-on-chronic liver failure, conditions associated with high morbidity and mortality. Emerging data indicate that the presence of CRGN infections in cirrhotic patients further worsens outcomes compared to non-cirrhotic individuals, emphasizing the need for focused clinical attention. Despite the recognized threat, comparative data investigating the clinical features, molecular resistance mechanisms, and patient outcomes of CRGN infections in sepsis with and without cirrhosis remain limited. Understanding differences in mortality, organ dysfunction, and risk factors between these groups is essential to optimize diagnostic and therapeutic strategies. Additionally, characterization of carbapenemase enzymes (e.g., KPC, NDM, VIM, OXA-48, IMP) responsible for resistance can guide effective antimicrobial therapy. This study aims to prospectively assess 30-day mortality in CRGN infections in sepsis patients with and without liver cirrhosis and to evaluate secondary outcomes including risk factors for infection, resistance patterns, organ dysfunction, ICU/hospital stay duration, and antibiotic susceptibility profiles, ultimately aiming to improve patient management and reduce mortality associated with these challenging infections. |