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CTRI Number  CTRI/2024/02/062173 [Registered on: 01/02/2024] Trial Registered Prospectively
Last Modified On: 10/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Registry 
Study Design  Single Arm Study 
Public Title of Study   Study on Fungal infection in blood in patients who had undergone Liver transplant. 
Scientific Title of Study   Registry of Fungemia in Liver Transplant ICU 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Keerti Brar 
Designation  Associate Consultant 
Affiliation  Medanta - The Medicity, Gurgaon 
Address  Department of Critical Care Medicine and Anesthesia Medanta – The Medicity, Sector 38, Gurgaon, Haryana

Gurgaon
HARYANA
122001
India 
Phone  9205177312  
Fax    
Email  keertibrar@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Keerti Brar 
Designation  Associate Consultant 
Affiliation  Medanta - The Medicity, Gurgaon 
Address  Department of Critical Care Medicine and Anesthesia Medanta – The Medicity, Sector 38, Gurgaon, Haryana


HARYANA
122001
India 
Phone  9205177312  
Fax    
Email  keertibrar@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Keerti Brar 
Designation  Associate Consultant 
Affiliation  Medanta - The Medicity, Gurgaon 
Address  Department of Critical Care Medicine and Anesthesia Medanta – The Medicity, Sector 38, Gurgaon, Haryana


HARYANA
122001
India 
Phone  9205177312  
Fax    
Email  keertibrar@hotmail.com  
 
Source of Monetary or Material Support  
Medanta the medicity Sector 38 Gurgaon Haryana 122001 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 
Dr Keerti Brar  Medanta - The Medicity, Gurgaon  Department of Critical Care Medicine and Anesthesia ICU 9, ICU 10, ICU 11 Medanta- the Medicity Sector 38, Gurgaon Haryana, India- 122001
Gurgaon
HARYANA 
9205177312

keertibrar@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medanta Institutional Ethics Committee (MIEC)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B377||Candidal sepsis, (2) ICD-10 Condition: B488||Other specified mycoses,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All Adult post liver transplant patients detected to have fungemia 
 
ExclusionCriteria 
Details  Paediatric patients less than 18years of age
Patients with diagnosed fungemia before admission to Intensive Care Unit
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Organisms identified
Sensitivity pattern
 
Till 28 days post surgery or discharge from hospital
 
 
Secondary Outcome  
Outcome  TimePoints 
Risk factor analysis

1 MELD Score pre operatively
2 Number of blood transfusions during surgery all cellular products
3 Re exploration within 28 days post operatively
4 Need for RRT post operatively
5 Neutropenia post operatively
6 Post operative bile leak
7 Immunosuppressant pre operatively
8 Parenteral Nutrition post operatively
9 Broad spectrum antimicrobial use along with duration
10 Bacterial or Viral infection
11 Acute Kidney Injury
12 Primary graft rejection or Failure
 
Till 28 days post surgery or discharge from hospital 
 
Target Sample Size   Total Sample Size="3000"
Sample Size from India="3000" 
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)   05/02/2024 
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="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

This study is to establish a comprehensive registry of patients with fungemia in the Liver Transplantation Intensive Care Unit at site. Data will be gathered by collaborative effort between the Critical care, Liver Transplantation and Microbiology team from 2010 to 2024. The primary objective of the study is to establish a registry of fungemia in patients admitted in Liver Transplant Unit at site to determine the Incidence of positive blood cultures for fungal infections in patients admitted to Liver Transplant ICU, to determine the causative species responsible for fungemia, to analyze the sensitivity patterns of anti fungal agents. Secondary objective of the study is to identify risk factors associated with fungemia. All adult post liver transplant patients detected to have fungemia will be included in the study. Paediatric patients (<18years of age) and patients with diagnosed fungemia before admission to Intensive Care Unit will be excluded from the study. End point of the study is till 28 days post-surgery or discharge from hospital. Primary outcome of the study is to identify organisms and their sensitivity pattern. Secondary outcome is risk factor analysis.

 

 
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