| CTRI Number |
CTRI/2021/03/032122 [Registered on: 18/03/2021] Trial Registered Prospectively |
| Last Modified On: |
28/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EVALUATE THE EFFECT OF USE OF TRIIDOTHYRONINE T3 HORMONE TABLET IN CHILDREN UNDERGOING HEART SURGERIES. |
|
Scientific Title of Study
|
EFFECT OF PERIOPERATIVE USE OF ORAL TRIIDOTHYRONINE FOR INFANTS UNDERGOING COMPLEX CONGENITAL CARDIAC SURGERIES UNDER CARDIOPULMONARY BYPASS: A DOUBLE BLINDED RANDOMISED CONTROLLED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUJITHAREDDY |
| Designation |
Senior Resident |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
department of Cardiac Anaesthesia, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09493843921 |
| Fax |
|
| Email |
sujithakarri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BANASHREE MANDAL |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
department of Cardiac Anaesthesia, PGIMER, Chandigarh
department of Cardiac Anaesthesia, PGIMER, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09493843921 |
| Fax |
|
| Email |
banashreemandal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sujitha Reddy Karri |
| Designation |
Senior Resident |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
department of Cardiac Anaesthesia, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09493843921 |
| Fax |
|
| Email |
sujithakarri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiac Anaesthesia, PGIMER |
|
|
Primary Sponsor
|
| Name |
Department of Cardiac Anaesthesia |
| Address |
department of cardiac anaesthesia, PGIMER, Chandigarh |
| 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 |
| sujithareddy karri |
PGIMER |
department of cardiac anaesthesia, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
09493843921
sujithakarri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| int/iec/2020 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I272||Other secondary pulmonary hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
oral triidothyronine |
we will give 10 doses of oral triidothyronine to patients starting from POD 1 |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
all children less than 1 year of age undergoing complex cardiac surgeries like arterial switch operation, vsd with PAH, TAPVC repair under CPB |
|
| ExclusionCriteria |
| Details |
Children who have history of radiation therapy, abnormal baseline thyroid function,
thyroid diseases and other endocrine diseases, preoperative thyroid hormone therapy,
use of drugs affecting thyroid function,
and preoperative use of inotropic drugs for circulatory support,
serum level of creatinine >2.0mg/dL downs syndrome mortality during study will be excluded from the study
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of Triidothyronine therapy on ionotropic requirement (mean ionotropic scores on 3rd postoperative day) in post complex congenital cardiac surgery under cardiopulmonary bypass
|
3rd postop day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare Thyroid hormone profile.
2.To compare left ventricular function by assessing Left ventricular outflow tract velocity time integral(LVOT VTi), Ejection by echo
3.To assess the effect of T3 on ionotropic requirement in post complex congenital cardiac surgeries in infants.
4.To compare pulmonary function by assessing PaO2/FiO2 Ratio.
5.To compare 24 hours fluid balance.
6.To compare ventilation time, ICU Length of stay.
7. Arrhythmias
8. Sepsisbetween the two groups
|
pod 0,1,2,4,5 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/04/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
Cardiopulmonary Bypass
(CPB) causes disruption of normal
homeostatic mechanisms and leads to various effects on different organ systems. Thyroid functions are also deranged by CPB leading to transient secondary hypothyroidism and sick euthyroid syndrome. We hypothesised that giving oral triido thyronine will decrease the ionotropic requirement and help
in enchancement of postoperative
recovery.
|