| CTRI Number |
CTRI/2026/03/105532 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Echocardiographic variables (GLS, LVOT-VTI, and RRI) as Predictors of Acute Kidney injury in patients under going On-Pump CABG |
|
Scientific Title of Study
|
Predictive ability of perioperative change in GLS , LVOT-VTI and RRI for occurrence of cardiac surgery associated AKI in patients undergoing elective on-pump CABG: An 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 |
Gursharan Singh |
| Designation |
Senior Resident Cardiothoracic and Vascular Anaesthesia |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical care All India Institute
of Medical Sciences (AIIMS), Industrial Area Basni, Phase 2,
Jodhpur, Rajasthan - 342005
Jodhpur
RAJASTHAN
342008
India |
| Phone |
9654863943 |
| Fax |
|
| Email |
gursharan3943@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar |
| Designation |
Additional professor |
| Affiliation |
Aiims Jodhpur |
| Address |
Department of Anaesthesiology and Critical care All India Institute
of Medical Sciences (AIIMS), Industrial Area Basni, Phase 2,
Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9460429221 |
| Fax |
|
| Email |
drrakeshspmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Kumar |
| Designation |
Additional professor |
| Affiliation |
Aiims Jodhpur |
| Address |
Department of Anaesthesiology and Critical care All India Institute
of Medical Sciences (AIIMS), Industrial Area Basni, Phase 2,
Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9460429221 |
| Fax |
|
| Email |
drrakeshspmc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical care |
| Address |
Department of Anaesthesiology and Critical care All India Institute
of Medical Sciences (AIIMS), Industrial Area Basni, Phase 2,
Jodhpur, Rajasthan - 342005 |
| Type of Sponsor |
Government medical college |
|
|
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 Rakesh Kumar |
Aiims Jodhpur |
Department of Anaesthesiology and Critical care All India Institute
of Medical Sciences (AIIMS), Industrial Area Basni, Phase 2,
Jodhpur, Rajasthan - 342005
Jodhpur
RAJASTHAN |
9460429221
drrakeshspmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| nstitutional Ethics Committee, 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
elective on pump CABG |
|
| ExclusionCriteria |
| Details |
Chronic kidney disease
emergency/redo/combined procedures,
non-sinus rhythm,
poor echo window,
preoperative critical state,
pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the predictive ability of perioperative changes in GLS, LVOT-VTI, and RRI for CSA-AKI; to determine their inter-relationships; and to assess whether combined indices improve early prediction of AKI and correlate with outcomes such as RRT requirement, mechanical ventilation, and ICU stay. |
variables Such as GLS, LVOT-VTI RRI will be measured pre pump ( before going on cardiopulmonary bypass), after Pump ( after coming off from cardiopulmonary bypass )
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. To predict the occurrence of AKI with LVOT VTI.
ii. To predict the occurrence of AKI with renal resistive index.
iii. To observe a relationship between change in GLS, LVOT-VTI & RRI
iv. To observe the post op duration of mechanical ventilation, ICU stay & Vaso-Inotropic Score (VIS).
|
variables Such as GLS, LVOT-VTI RRI will be measured pre pump ( before going on cardiopulmonary bypass), after Pump ( after coming off from cardiopulmonary bypass ) & 48 hours |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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)
|
16/03/2026 |
| 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="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 - NO
|
|
Brief Summary
|
Cardiac surgery–associated acute kidney injury (CSA-AKI) affects nearly one in four patients undergoing cardiopulmonary bypass (CPB) and significantly increases morbidity and mortality. Conventional hemodynamic monitoring often fails to identify early renal hypoperfusion. Echocardiographic indices such as global longitudinal strain (GLS) and left ventricular outflow tract velocity–time integral (LVOT-VTI) assess myocardial performance and forward flow, while renal resistive index (RRI) reflects intrarenal vascular resistance. Integrating these parameters may enable early detection of renal compromise in high-risk patients.
PICOT Framework: P (Population): Adults (>18 years) undergoing elective on-pump CABG. I (Intervention/Exposure): Perioperative changes in GLS, LVOT-VTI, and RRI. C (Comparison): Patients without significant change in these parameters. O (Outcome): Development of CSA-AKI (KDIGO 2012 criteria). T (Time): Within 48 hours post-surgery. Research Question: Do perioperative changes in GLS, LVOT-VTI, and RRI predict CSA-AKI in patients with reduced ejection fraction undergoing on-pump CABG? Aims and Objectives: To evaluate the predictive ability of perioperative changes in GLS, LVOT-VTI, and RRI for CSA-AKI; to determine their inter-relationships; and to assess whether combined indices improve early prediction of AKI and correlate with outcomes such as RRT requirement, mechanical ventilation, and ICU stay.
|