| CTRI Number |
CTRI/2026/01/102570 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Does adding kidney disease to a frailty score improve predictions of post surgery complications for kidney patients undergoing non cardiac surgery |
|
Scientific Title of Study
|
Does addition of chronic kidney disease to modified frailty index (mF11) alter postoperative risk prediction in CKD patients undergoing non cardiac surgery- An observational study |
| Trial Acronym |
CKD and frailty |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAlka Sachin Deo |
| Designation |
Chief Anaesthesiologist |
| Affiliation |
NU Hospitals, Bangalore |
| Address |
Lumbini 24, Palace Garden Apartments, Palace cross Road
Bangalore
NU Hospitals,
C. A 6 15th Main, 11th Cross, Padmanabhnagar, Bangalore
Bangalore
KARNATAKA
560020
India |
| Phone |
9880004508 |
| Fax |
|
| Email |
dr.alkadeo@nuhospitals.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAlka Sachin Deo |
| Designation |
Chief Anaesthesiologist |
| Affiliation |
NU Hospitals, Bangalore |
| Address |
NU Hospitals,
C. A 6 15th Main, 11th Cross, Padmanabhnagar, Bangalore
NU Hospitals,
C. A 6 15th Main, 11th Cross, Padmanabhnagar, Bangalore
Bangalore
KARNATAKA
560070
India |
| Phone |
9880004508 |
| Fax |
|
| Email |
dr.alkadeo@nuhospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAlka Sachin Deo |
| Designation |
Chief Anaesthesiologist |
| Affiliation |
NU Hospitals, Bangalore |
| Address |
NU Hospitals,
C. A 6 15th Main, 11th Cross, Padmanabhnagar, Bangalore
NU Hospitals,
C. A 6 15th Main, 11th Cross, Padmanabhnagar, Bangalore
Bangalore
KARNATAKA
560070
India |
| Phone |
9880004508 |
| Fax |
|
| Email |
dr.alkadeo@nuhospitals.com |
|
|
Source of Monetary or Material Support
|
| NU Hospitals,C. A. 6, 15th Main, 11th Cross, Padmanabhnagar, Bangalore 560070 Karnataka |
|
|
Primary Sponsor
|
| Name |
NU Hospitals |
| Address |
C.A. 6 15th Main, 11th Cross Padmanabhnagar, Bangalore |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alka Sachin Deo |
NU Hospitals |
Department of Anaesthesia ,Room 923, OT Complex, First Floor, C. A. 6 15th Main, 11th Cross, Padmanabhnagar, Bangalore
Bangalore
KARNATAKA |
080-42489923
dr.alkadeo@nuhospitals.com |
| Dr Annapurnashewari |
NU Hospitals West |
Department of Anaesthesia, Room no 5923 , 3 Floor , OT Complex #4/1, West of Chord Road, Near ISkcon, Rajajinagar, Bangalore
560010
Bangalore
KARNATAKA |
080-42489999
dr.annapurneshwari@nuhospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NU Hospitals Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (2) ICD-10 Condition: N19||Unspecified kidney failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years of age with eGFR less than 60 undergoing non cardiac surgery |
|
| ExclusionCriteria |
| Details |
Patients not consenting for study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess whether addition of CKD as one of the variable in modified frailty scoring alter risk prediction of mFI in patients undergoing non cardiac surgeries. |
30 days post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of frailty with postoperative complications |
30 days post surgery |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
10/02/2026 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Chronic kidney disease is a public health hazard.Frailty is common in those with chronic kidney
disease (CKD). ). The prevalence of frailty in the
community-dwelling older adult population is reported to be 11%, whereas
studies have reported a frailty prevalence of >60% in dialysis dependent CKD patients. There
are multiple tools and indices to assess frailty. The European Renal Best
Practice (ERBP) Working Group released a guidelines on the management of
elderly CKD patients with eGFR less than 45ml with an emphasis on functional
decline in advanced stages of renal failure.The
modified frailty index (mFI) score is a measure of frailty that reflects the
likely compromise of organ function due to patients’ co-morbidities . It has been validated across various surgical
specialties. The
above scoring system doesn’t include CKD as a variable, hence this study aims
in analyzing if inclusion of CKD as a
variable to mF11 alters its risk prediction |