| CTRI Number |
CTRI/2026/01/101861 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
11/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
The role of Glycemic Stress Index in Postoperative Outcomes after Cardiac Surgery in children with Acyanotic Congenital Heart Disease and Pre-existing Pulmonary Hypertension. |
|
Scientific Title of Study
|
The Correlation between Glycemic Stress Index and Postoperative Outcomes after Cardiac Surgery in Acyanotic Congenital Heart Disease Patients with Pre-existing Pulmonary Hypertension: A Prospective Single-centre Observational Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohan Magoon |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ABVIMS and DR RML HOSPITAL NEW DELHI |
| Address |
Department of Cardiac Anaesthesia, ABVIMS and Dr RML Hospital. Baba Kharak Singh Marg, Delhi-110001, INDIA.
Central
DELHI
110001
India |
| Phone |
9711128628 |
| Fax |
|
| Email |
rohanmagoon21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanya Mital |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ABVIMS and DR RML HOSPITAL NEW DELHI |
| Address |
Department of Cardiac Anaesthesia, second floor CTVS OT, ABVIMS and Dr RML Hospital. Baba Kharak Singh Marg, Delhi-110001, INDIA.
Central
DELHI
110001
India |
| Phone |
9958893940 |
| Fax |
|
| Email |
tanyamital3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanya Mital |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ABVIMS and DR RML HOSPITAL NEW DELHI |
| Address |
Department of Cardiac Anaesthesia, second floor CTVS OT, ABVIMS and Dr RML Hospital. Baba Kharak Singh Marg, Delhi-110001, INDIA.
Central
DELHI
110001
India |
| Phone |
9958893940 |
| Fax |
|
| Email |
tanyamital3@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institutional support ABVIMS and DR RML HOSPITAL |
| Address |
ABVIMS and Dr RML Hospital, Baba Kharak Singh Marg, Delhi 110001, INDIA. |
| 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 |
| DR ROHAN MAGOON |
ABVIMS and Dr RML Hospital, New Delhi |
Department of Cardiac Anaesthesia, second floor CTVS OT, Baba Kharak Singh Marg, Delhi 110001, INDIA.
Central
DELHI |
9711128628
rohanmagoon21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECABVIMSRMLH |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Acyanotic Congenital Heart Disease undergoing elective cardiac surgery requiring cardiopulmonary bypass with Pre-existing PH confirmed preoperatively by echocardiography and/or catheterization. |
|
| ExclusionCriteria |
| Details |
Neonates
Known preoperative hyperglycemia or diabetes mellitus.
Liver failure, inborn errors of metabolism.
Developmental delay
Preoperative systemic steroid therapy.
Critical preoperative state with ionotropic or vasopressor support/ sepsis
Preoperative parenteral or intravenous nutrition.
ECMO
Emergency surgery.
Redo surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the correlation between GSI and
Pediatric intensive care unit (PICU) length of stay (hours), and
Duration of mechanical ventilation (hours) during the index postoperative admission.
|
Blood glucose will subsequently be measured at the following time points: after induction of anesthesia, at CPB initiation, every 30 mins on CPB, post CPB, at the end of surgery (post skin closure), upon PICU admission, and at 24 hours postoperatively. Duration of postoperative ventilation (hours) and PICU length of stay (hours) will be recorded in the ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess correlations between GSI and Preoperative PASP (mmHg), and Postoperative mean vasoactive-inotropic score (VIS).
|
Blood glucose will subsequently be measured at the following time points: after induction of anesthesia, at CPB initiation, every 30 mins on CPB, post CPB, at the end of surgery (post skin closure), upon PICU admission, and at 24 hours postoperatively. Preoperative echocardiographic estimates for PAH cateogarisation.VIS at PICU admission and 24 hrs postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
05/02/2026 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This prospective single centre observational study will assess the correlation between Glycemic Stress Index and postoperative outcomes in children with acyanotic congenital heart disease and pre existing pulmonary hypertension undergoing elective cardiac surgery. The study aims to determine whether higher Glycemic Stress Index values are associated with prolonged mechanical ventilation, longer pediatric intensive care unit stay, and increased postoperative complications. Approximately 95 participants will be enrolled. Findings are expected to clarify the role of intraoperative glycemic stress as a predictor of adverse outcomes in high risk pediatric cardiac surgical patients. |