| CTRI Number |
CTRI/2024/04/065288 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observation of effects of cardiopulmonary bypass (heart lung machine) used in heart surgery on Thyroid gland function tests in normal patients and in patients who are taking Thyroid medications |
|
Scientific Title of Study
|
Prospective observational study of effects of cardiopulmonary bypass in cardiac surgery on thyroid function tests in euthyroid patients and in patients on thyroid medications |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjeeta Umbarkar |
| Designation |
Professor(Add.) and HOD |
| Affiliation |
Seth G. S. Medical College and K. E. M Hospital |
| Address |
Department of Cardiac Anesthesia, Seth G S Medical College and K E M Hospital, Parel, Mumbai, Maharashtra 400012, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9323273435 |
| Fax |
|
| Email |
sanjeeta69@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjeeta Umbarkar |
| Designation |
Professor(Add.) and HOD |
| Affiliation |
Seth G. S. Medical College and K. E. M Hospital |
| Address |
Department of Cardiac Anesthesia, Seth G S Medical College and K E M Hospital, Parel, Mumbai, Maharashtra 400012, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9323273435 |
| Fax |
|
| Email |
sanjeeta69@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjeeta Umbarkar |
| Designation |
Professor(Add.) and HOD |
| Affiliation |
Seth G. S. Medical College and K. E. M Hospital |
| Address |
Department of Cardiac Anesthesia, Seth G S Medical College and K E M Hospital, Parel, Mumbai, Maharashtra 400012, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9323273435 |
| Fax |
|
| Email |
sanjeeta69@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Seth G S Medical College and K E M Hospital, Parel, Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Sanjeeta Umbarkar |
| Address |
Professor(Add) and Head of Department of Cardiac Anesthesia, Seth G S Medical College and K E M Hospital, Parel, Mumbai, Maharashtra 400012, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Sanjeeta Umbarkar |
CVTC Building, Seth G S Medical College and K E M Hospital, Mumbai |
Room 305, Department of Cardiac Anesthesia, Ground floor, CVTC building, Seth G S Medical College and K E M Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9323273435
sanjeeta69@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC)- III, Relating to Biomedical and Health Research, Seth G S Medical College and K E M Hospital, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I050||Rheumatic mitral stenosis, (2) ICD-10 Condition: I051||Rheumatic mitral insufficiency, (3) ICD-10 Condition: I052||Rheumatic mitral stenosis with insufficiency, (4) ICD-10 Condition: I058||Other rheumatic mitral valve diseases, (5) ICD-10 Condition: I059||Rheumatic mitral valve disease, unspecified, (6) ICD-10 Condition: I060||Rheumatic aortic stenosis, (7) ICD-10 Condition: I061||Rheumatic aortic insufficiency, (8) ICD-10 Condition: I062||Rheumatic aortic stenosis with insufficiency, (9) ICD-10 Condition: I068||Other rheumatic aortic valve diseases, (10) ICD-10 Condition: I069||Rheumatic aortic valve disease, unspecified, (11) ICD-10 Condition: I070||Rheumatic tricuspid stenosis, (12) ICD-10 Condition: I072||Rheumatic tricuspid stenosis and insufficiency, (13) ICD-10 Condition: I071||Rheumatic tricuspid insufficiency, (14) ICD-10 Condition: I078||Other rheumatic tricuspid valve diseases, (15) ICD-10 Condition: I079||Rheumatic tricuspid valve disease,unspecified, (16) ICD-10 Condition: I080||Rheumatic disorders of both mitraland aortic valves, (17) ICD-10 Condition: I081||Rheumatic disorders of both mitraland tricuspid valves, (18) ICD-10 Condition: I082||Rheumatic disorders of both aorticand tricuspid valves, (19) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing cardiac surgery with cardiopulmonary bypass |
|
| ExclusionCriteria |
| Details |
1. Non cardiac surgery
2. Cardiac surgery without cardiopulmonary bypass
3. Any other previous endocrine abnormality preoperatively
4. Emergency cardiac surgery with or without cardiopulmonary bypass |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in free t3, free t4 and tsh levels in the preoperative and postoperative period
|
Before surgery
24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Correlation of changes in thyroid function with aortic cross clamp and cp bypass duration
2. Postoperative hemodynamics
3. Compare outcomes in preoperative euthyroid and patients on thyroid medication |
6,12,18,24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
19/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Cardiopulmonary bypass used in various cardiac surgeries has effects on various organ systems. This study intends to observe effects of cardiopulmonary bypass on thyroid function tests. Patients posted for cardiac surgery with cardiopulmonary bypass will be recruited in the study. After thorough pre-operative assessment, their pre-operative Thyroid function values (Serum Free T3, Serum Free T4 and Serum TSH) will be recorded. Presence or absence of any previous thyroid disorder will be recorded along with thyroid medications. Surgery will be conducted under standard protocol. Total cardiopulmonary bypass duration, aortic cross clamp duration, temperature and perfusion pressure during bypass duration will be recorded. Thyroid functions tests (Serum Free T3, Serum Free T4 and Serum TSH) will be repeated 24 hours after surgery. Difference in Thyroid function will be analyzed for statistical significance. At the same time, correlation of the difference in Thyroid function tests with post operative ICU course will be observed and analyzed for statistical significance. |