| CTRI Number |
CTRI/2020/02/023596 [Registered on: 26/02/2020] Trial Registered Prospectively |
| Last Modified On: |
09/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the association between frailty before surgery and delirium after surgery in cardiac surgery patients. |
|
Scientific Title of Study
|
A Prospective observational study designed to study the association between preoperative frailty and postoperative delirium in cardiac surgery patients. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manish Patil |
| Designation |
Assistant Professor |
| Affiliation |
B.Y.L. Nair Ch. Hospital And T.N. Medical college, Mumbai central |
| Address |
Department of Anaesthesiology,
B.Y.L. Nair Ch. Hospital And T.N. Medical college, Mumbai central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9004025170 |
| Fax |
|
| Email |
drmanishpatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Kolte |
| Designation |
Senior Resident |
| Affiliation |
B.Y.L. Nair Ch. Hospital And T.N. Medical college, Mumbai central |
| Address |
Department of Anaesthesiology,
B.Y.L. Nair Ch. Hospital And T.N. Medical college, Mumbai central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8805305883 |
| Fax |
|
| Email |
kolte.poonam10293@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Kolte |
| Designation |
Senior Resident |
| Affiliation |
B.Y.L. Nair Ch. Hospital And T.N. Medical college, Mumbai central |
| Address |
Department of Anaesthesiology,
B.Y.L. Nair Ch. Hospital And T.N. Medical college, Mumbai central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8805305883 |
| Fax |
|
| Email |
kolte.poonam10293@gmail.com |
|
|
Source of Monetary or Material Support
|
| B.Y.L. Nair Ch. Hospital & T.N. Medical college, Mumbai central. |
|
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Primary Sponsor
|
| Name |
BYL Nair Ch Hospital And TN Medical college Mumbai central |
| Address |
B.Y.L. Nair Ch. Hospital And T.N. Medical college, Mumbai central 40008 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poonam Kolte |
B.Y.L. Nair Ch. Hospital, |
Department of anesthesiology
Mumbai
MAHARASHTRA |
8805305883
kolte.poonam10293@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECARP/2017/173 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (2) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective cardiac surgery which includes cardiac bypass surgery and valvular heart disease repair surgery. |
|
| ExclusionCriteria |
| Details |
1) Emergency Cardiac surgery.
2)K/C/O psychiatric illness.
3) Patients in whom delirium cannot be assessed reliably like patients with previous stroke, cerebral palsy, severe dementia, severe hearing disabilities,
4) Patients refusal to give consent. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| association between preoperative frailty and postoperative delirium in cardiac surgery patients. |
2 weeks |
|
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Secondary Outcome
|
|
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Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="152" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
Background: The study aimed to evaluate the association between preoperative frailty and postoperative delirium in patients undergoing elective cardiac surgery.
Methods: A prospective observational study was conducted. Frailty was assessed preoperatively using four tools:
Postoperative delirium was assessed every 12 hours for 7 days using the Confusion Assessment Method for ICU (CAM-ICU).
Results: Fried Frailty Criteria: 63.8% were frail; 49.5% of them developed delirium vs. 13.3% in non-frail patients. SPPB: 61.2% were frail; 50.5% of these developed delirium. EFS: 47.37% of frail patients developed delirium; delirious patients had significantly higher EFS scores (p=0.001). 35-Item Frailty Index: Delirium occurred in 12.5% (FI 0.2–0.3), 19% (FI 0.31–0.4), and 56.95% (FI >0.4). Higher FI correlated significantly with delirium (p<0.001).
Conclusion: All four frailty assessment methods effectively predicted postoperative delirium. The Fried Frailty Criteria and SPPB showed high negative predictive values (87.27% and 87.95%, respectively). The 35-Item Frailty Index quantified frailty severity, with higher scores indicating greater delirium risk. Overall, preoperative frailty was strongly associated with an increased incidence of postoperative delirium, highlighting frailty assessment as a valuable predictive tool in cardiac surgery patients.
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