| CTRI Number |
CTRI/2025/07/090181 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Occurrence of kidney failure in ICU patients |
|
Scientific Title of Study
|
Acute Kidney Injury Epidemiology in ICU patients 2 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AKI - EPI2, Version 1.0, Dated 17 June 2024 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Govil |
| Designation |
Vice Chairman |
| Affiliation |
Medanta The Medicity Gurgaon |
| Address |
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
09818056688 |
| Fax |
|
| Email |
drdeepak_govil@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Govil |
| Designation |
Vice Chairman |
| Affiliation |
Medanta The Medicity Gurgaon |
| Address |
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
09818056688 |
| Fax |
|
| Email |
drdeepak_govil@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Govil |
| Designation |
Vice Chairman |
| Affiliation |
Medanta The Medicity Gurgaon |
| Address |
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
09818056688 |
| Fax |
|
| Email |
drdeepak_govil@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Ghent University Hospital
C Heymanslaan 10 9000 Ghent Belgium |
|
|
Primary Sponsor
|
| Name |
Ghent University Hospital |
| Address |
C Heymanslaan 10 9000 Ghent Belgium |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Austria
Belgium
Denmark
Greece
Spain
Australia
Bolivia
Bosnia and Herzegovina
Brazil
Canada
Chile
China
Colombia
Croatia
Ecuador
Egypt
Finland
France
Georgia
Germany
Hungary
Ireland
Israel
Italy
Japan
Kuwait
Malaysia
Mexico
Netherlands
Portugal
Republic of Korea
Russian Federation
Saudi Arabia
Singapore
Slovenia
South Africa
Sweden
Switzerland
Taiwan
Thailand
Tunisia
Turkey
United Kingdom
United States of America
Uruguay
Iran (Islamic Republic of) |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anand Gupta |
Asian Institute of Gastroenterology |
6 3 661 Somajiguda
Hyderabad 500082
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
9313392757
drandygrmc@gmail.com |
| Dr Vaibhav Bhargava |
Fortis Escorts Hospital |
Jawhar Lal Nehru Marg
Malviya Nagar Jaipur
302017
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
9928787788
drvaibhav79@gmail.co m |
| Dr Akshay H M |
JSS Medical College |
Sri Shivarathreeshwara Nagara, Mysuru 570 015 Karnataka
Mysore
KARNATAKA
Mysore
KARNATAKA |
9886222812
hmmakshay@gmail.com |
| Dr Smita Jain |
Medanta Super speciality Hospital Indore |
Plot No 8 PU4
Scheme no 54 Vijay
Nagar Square A B
Road Indore 452010
India
Indore
MADHYA PRADESH |
09425900760
Smita.Sarma@medanta.org |
| Dr Deepak Govil |
Medanta The Medicity |
Institute of Critical Care and Anesthesiology ICU 9 10 11 12 2nd floor Medanta The Medicity 122001
Gurgaon
HARYANA |
09818056688
drdeepak_govil@yahoo.co.in |
| Dr Kapil Zirpe |
Ruby Hall Clinic |
40 Sassoon Road Pune
411001
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9822844212
kapilzirpe@gmail.com |
| Dr Madhusudan R Jaju |
Yashoda Academy of Medical Education and Research |
Yashoda Hospital Behind Harihara Kala Bhavan Secunderabad
Hyderabad
TELANGANA |
8668459383
madhu_jaju123@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Asian Institute of Gastroenterology IEC AIG |
Approved |
| Institutional Ethics Committee Biomedical and Health Research PMRF |
Approved |
| Institutional Ethics Committee Fortis Hospital, Jaipur |
Approved |
| Institutional Ethics Committee Fortis Hospital, Jaipur |
Approved |
| Institutional Ethics Committee Yashoda Academy of Medical Education and Research |
Approved |
| Medanta Indore Institutional Ethics Committee |
Approved |
| Medanta Institutional Ethics Committee (MIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N179||Acute kidney failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Age more than equal to 18 years
2 Admitted to one of the participating ICUs
3 Admitted to the ICU for more than 24 hours or anticipated length of stay in the ICU for 24 hours or more
4 Informed consent according to local ethical committee |
|
| ExclusionCriteria |
| Details |
1 Readmission to the ICU during the same hospitalization episode
2 End Stage Kidney Disease treated with maintenance RRT
3 Missing AKI defining data no measured serum creatinine and less than 6 hours of documented urinary output |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Occurence rate and maximum severity of AKI within 7 days of ICU admission
|
Within 7 days of ICU admission
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Duration of AKI episodes within first week of ICU admission
2 Proportion of AKI with rapid reversal
3 Incidence of acute kidney disease
4 Use of RRT within 7 days of ICU admission
5 RRT free days during ICU admission
6 Type & specifics of applied RRT
7 Proportion of patients without baseline creatinine
8 Length of stay in the ICU & post ICU in the hospital & total length of stay in the hospital
9 ICU & Hospital readmission upto day 90
10 Serum creatinine level at ICU & hospital discharge
11 RRT dependence at hospital discharge
12 Mortality at hospital discharge
13 Magnitude of AKI area under the curve of AKI of severity over time
14 Incidence of AKI & maximum AKI severity stage defined by serum creatinine & or urine output criteria only
|
At day 7
At day 90 |
|
|
Target Sample Size
|
Total Sample Size="10642"
Sample Size from India="2500"
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)
|
21/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Acute Kidney Injury or AKI is a frequent complication in critically ill patients admitted to the intensive care unit. There are little data on biomarkers, renal replacement therapy and practices are available. The primary objective of this study is to provide a contemporary update on the epidemiology of AKI and associated outcomes in critically ill patients. The secondary object of this study is to assess temporal aspects of AKI, to describe utilization and practice of RRT and to explore differences in rates and outcomes between regions and health care systems according to geographical location and resources. This is an international, multicenter cohort study. Patients who are Age greater than equal to 18 years of age admitted to the participating ICU for more than 24-h, or anticipated length of stay in the ICU for 24 hour or more will be included in the study. The primary outcome of the study is see the occurence rate and maximum severity of AKI within 7 days of ICU admission.
|