| 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
|
|
|
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
|
|
|
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. |