| CTRI Number |
CTRI/2020/02/023319 [Registered on: 13/02/2020] Trial Registered Prospectively |
| Last Modified On: |
12/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Detection of acute kidney injury in intensive care units using novel urine test. |
|
Scientific Title of Study
|
Biomarker enhanced management of acute kidney injury in Indian patients |
| Trial Acronym |
BEMAKI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajasekara Chakravarthi |
| Designation |
Sr. Consultant Nephrologist and Director Neprhology |
| Affiliation |
Star Hospitals |
| Address |
8-2-596/5, Road No.10,Star Hospital,Department of Nephrology,Block C,Room No 3101,
Banjara Hills, Hyderabad.
Renown Clinical Services,Flat No 2,Meghana Edifice,Road No 3,Banjara Hills,Hyderabad-500034
Hyderabad
TELANGANA
500034
India |
| Phone |
04044777777 |
| Fax |
|
| Email |
rajasekarac@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajasekara Chakravarthi |
| Designation |
Sr. Consultant Nephrologist and Director Neprhology |
| Affiliation |
Star Hospitals |
| Address |
8-2-596/5, Road No. 10,Star Hospital,Block C,Room No 3101,
Banjara Hills, Hyderabad.
Renown Clinical Services,Flat No 2,Meghana Edifice,Road No 3,Banjara Hills,Hyderabad
renownclinicalservices@gmail.com
Hyderabad
TELANGANA
500034
India |
| Phone |
04044777777 |
| Fax |
|
| Email |
rajasekarac@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girish Vasudeo Kumthekar |
| Designation |
Consultant Nephrologist |
| Affiliation |
Star Hospitals |
| Address |
8-2-596/5, Road No. 10,Department of Nephrology,Block C,Room 3017,
Banjara Hills, Hyderabad.
Renown Clinical Services,Flat No 2,Meghana Edifice,Road No 3,Banjara Hills,Hyderabad.
renownclinicalservices@gmail.com
Hyderabad
TELANGANA
500034
India |
| Phone |
04044777777 |
| Fax |
|
| Email |
drgirishkumthekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| BioMerieux,100 Rue Louis Pasteur, 69280 Marcy-lÉtoile, France |
|
|
Primary Sponsor
|
| Name |
BioMerieux India Pvt Ltd |
| Address |
43A, Okhla phase 3, MODI mill compound, New Delhi-110020 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prathim Senugupta |
ILS Hospital |
Nephrology Department
Dumdum 1
Mall Road
Near Nagerbazar flyover
700080
Kolkata
WEST BENGAL |
9830159686
pratim.sengupta@gmail.com |
| Dr Ramesh Venkatraman |
Apollo Hospitals |
Dept. of CCM, Main block, 21, Greams Lane, Off Greams Road
Chennai - 600006
Chennai
TAMIL NADU |
9940219670
ccmramesh@gmail.com |
| Dr Soma Sekhara |
Apollo Hospitals |
Room no. 43
Nephrology department
JubileeHills.
Hyderabad 500096
Hyderabad
TELANGANA |
9391384659
mssekhar_58@rediffmail.com |
| Dr Manjunath Shetty |
J. S. S. Medical college hospital |
Department of Nephrology, Opposite J.S.S.Pharmacy College, Bannimantap A Layout, Bannimantap, Mysuru, Karnataka 570015
Mysore
KARNATAKA |
9880739069
manju.doshetty@gmail.com |
| Dr Sreejith Parameswaran |
JIPMER |
Department of Nephrology
#5348, Super Speciality Block
JIPMER campus
Dhanvantari Nagar P. O.,
Puducherry - 605006
Pondicherry
PONDICHERRY |
9489148338
sparameswaran@outlook.com |
| Dr Valentine Lobo |
KEM Hospital, Pune |
Dept of Nephrology
89, Sardar Moodliar Road, Rasta Peth, Pune, Maharashtra 411011
Pune
MAHARASHTRA |
8087847826
valentinelobo@rediffmail.com |
| Dr Deepak Govil |
Medanta Medicity Hospital |
Department of Critical Care Medicine
Near Olympus, CH Baktawar Singh Rd, Sector 38, Gurugram, 122001
New Delhi
DELHI |
9818056688
drdeepak_govil@yahoo.co.in |
| Dr Vivek Kumar |
PIGMER |
Department of Nephrology
Sector 12, Chandigarh-160012
Chandigarh
CHANDIGARH |
7087429731
enigma165@yahoo.co.in |
| Dr Narayan Prasad |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
Department of Nephrology, Raebareli Rd, Haibat Mau Mawaiya, Lucknow, Uttar Pradesh 226014
Lucknow
UTTAR PRADESH |
9415403140
narayan.nephro@gmail.com |
| Dr Piyush Mathur |
Santokba Durlabhji Memorial Hospital |
Department of Nephrology
Bhawani Singh Marg, Near, Rambagh circle, Jaipur, Rajasthan 302015
Jaipur
RAJASTHAN |
7023333189
piyushnephro@gmail.com |
| Dr I Chandana Reddy |
Star Hospitals |
Pulmonary and critical care department
Room No. 101
A block 1st floor
8-2-596/5, Road No. 10
Banjara Hills, Hyderabad- 500034
Hyderabad
TELANGANA |
9866284070
drchandanasekhar@gmail.com |
| Dr Srinivas Samvedam |
Virinchi Hospitals |
Department of Critical Care Medicine,
Virinchi Circle, Rd Number 1, Shyam Rao Nagar, Banjara Hills, Hyderabad, Telangana 500034
Hyderabad
TELANGANA |
9866343632
srinivas3271@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Ethics Apollo Hospitals Enterprise Limited Chennai, |
Submittted/Under Review |
| Ethics committe Apollo Hospitals, Hyderabad |
Submittted/Under Review |
| ILS Hospital Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee - JSSMC |
Submittted/Under Review |
| Institutional Ethics Committee - KEM Hospital Research Center |
Submittted/Under Review |
| Institutional Ethics Committee for Observational Studies JIPMER |
Submittted/Under Review |
| Institutional Ethics Committee of Santokba Durlabhji Memorial Hospital cum Medical Research Institute |
Submittted/Under Review |
| Institutional Ethics Committee PGIMER |
Submittted/Under Review |
| Institutional Ethics Committee SGPGI |
Submittted/Under Review |
| Institutional Ethics Committee Star Hospitals |
Approved |
| Medanta Institutional Ethics Committee (MIEC) |
Submittted/Under Review |
| Virinchi Hospitals |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age > 18 admitted to ICUs
Diagnosis of sepsis or following major surgery.
High risk of developing AKI based on the Malhotra score > 88 |
|
| ExclusionCriteria |
| Details |
Unable to give consent and absence of any surrogate to give consent
Chronic hemodialysis or peritoneal dialysis within the past 12 months
Functioning kidney transplantation
Patients not expected to survive more than 48 h
Prisoners |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of acute kidney injury. |
Day 7 after enrollment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Requirement of dialysis.
2.length of hospital and ICU stay.
3.Mortality.
4.Development of chronic kidney disease. |
day 90 after enrollment. |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
14/02/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acute Kidney Injury (AKI) is a complex disorder encountered from 5% in hospitalized patients and 40-60% in ICU setting. it is associated with high mortality and increased resource utilization . Clinical trials have demonstrated the efficacy of these new biomarkers in detecting kidney damage, predicting disease progression and determining potential recovery. Two Randomized clinical trials have shown the efficacy of TIMP2 and IGFBP biomarkers in Cardiac surgery (PREVAKI)2 and high risk surgery patients (BIGPAK)3 to improve outcomes. Unfortunately the adoption of damage biomarkers into routine clinical care worldwide has been limited. In This study we propose to characterize the utility of nephrocheck in the diagnosis, differentiation and management of AKI in patients with sepsis and major surgery in the ICU across multiple centers in india provide new information on patterns of AKI development, course and management and ascertain the barriers to boimarker applications in this setting. The data obtained will inform the development of best practices for optimal utilization of the nephrocheck markers to improve outcomes from AKI. |