| CTRI Number |
CTRI/2025/04/084008 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefit of thyroid supplementation on patients with asymptomatic hypothyroidism undergoing Coronary Bypass Grafting surgery |
|
Scientific Title of Study
|
Impact of thyroid hormone supplementation on postoperative care in patients with subclinical hypothyroidism following on-pump coronary bypass grafting surgery- A randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikram Pal |
| Designation |
Doctor-Junior Resident - McH-Cardiothoracic and Vascular Surgery (6 years) |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department Of Cardiothoracic and Vascular Surgery,
AIIMS Jodhpur- Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9972966223 |
| Fax |
|
| Email |
vppal23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Sharma |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department Of Cardiothoracic and Vascular Surgery,
AIIMS Jodhpur- Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9166553222 |
| Fax |
|
| Email |
sharmaak@aiimsjodhpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vikram Pal |
| Designation |
Doctor-Junior Resident - McH-Cardiothoracic and Vascular Surgery (6 years) |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department Of Cardiothoracic and Vascular Surgery,
AIIMS Jodhpur- Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9972966223 |
| Fax |
|
| Email |
vppal23@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vikram Pal |
AIIMS Jodhpur |
Department of Cardiothoracic and Vascular Surgery
4th floor(4C) - 446 room number
Jodhpur
RAJASTHAN |
9972966223
vppal23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Clinical trial)- AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (2) ICD-10 Condition: E038||Other specified hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug type |
Given oral levothyroxine 25 mcg and oral liothyronine 5 mcg once Daily, orally , given till duration of study |
| Comparator Agent |
No hormone supplementation |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.All consenting patients
2.age of 18 to 80 years
3.undergoing elective on pump coronary bypass grafting surgery
4.TSH levels between 4.5 to 8mIU per mililitre |
|
| ExclusionCriteria |
| Details |
1.Patients of age older than 80 years or younger than 18 years
2.Patients undergoing emergency surgery or re-do CABG operation
3.Patients undergoing concomitant valve surgery along with CABG in the same operation.
oPatients with TSH levels greater than 8mIU/L
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be the comparison of ICU stay duration between the two groups (thyroid supplementation vs. no supplementation) |
Compared postoperatively, at end of 1 month postoperatively, 2 months postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes include the duration of mechanical ventilation, hospital stay, incidence of arrhythmias, need for IABP, and 30-day mortality. |
Postoperative day 0,1,2 and 30 |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
12/04/2025 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vppal23@gmail.com].
- For how long will this data be available start date provided 01-07-2026 and end date provided 01-01-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study investigates the impact of thyroid hormone supplementation on postoperative care for patients with subclinical hypothyroidism undergoing elective on-pump coronary artery bypass grafting (CABG) surgery. Subclinical hypothyroidism (SCH) is characterized by elevated TSH levels with normal thyroid hormone levels, which can affect cardiac function and recovery after surgery. The study aims to assess whether thyroid supplementation improves postoperative outcomes, particularly ICU stay duration, mechanical ventilation time, and the incidence of arrhythmias.
The study is a randomized controlled trial conducted at AIIMS Jodhpur, involving patients between 18 and 80 years undergoing elective CABG. Patients are divided into two groups: one group receives thyroid hormone supplementation (levothyroxine and liothyronine), while the other does not. The primary objective is to evaluate the impact of thyroid supplementation on ICU stay, with secondary objectives including assessing mechanical ventilation time, hospital stay, arrhythmias, and need for inotropic support.
The study uses a sample size of 82 patients, considering feasibility within the time constraints. Data is collected on preoperative, intraoperative, and postoperative variables, including TSH levels, inflammatory markers, and postoperative complications. Statistical analysis will be performed using multivariable logistic regression and Cox proportional hazards regression to compare the two groups.Ethically, the study will be conducted after obtaining patient consent, with the potential to update clinical practices and improve postoperative care for this group of patients. If successful, thyroid supplementation may shorten ICU stay, reduce the need for inotropes, and enhance recovery outcomes after CABG surgery. |