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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  
NIL 
 
Primary Sponsor  
Name  Dr Aditya Parashar 
Address  Amrita Hospital Faridabad 121002  
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 
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