| CTRI Number |
CTRI/2026/03/106351 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Predicting kidney and liver injury following heart surgery using an ultrasound based scoring system done before surgery in patients with heart disease. |
|
Scientific Title of Study
|
Venous excess ultrasound score in mitral valve disease patients undergoing mitral valve surgery and risk of post-operative kidney and liver injury: A prospective 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 |
Dr Shindhujaa A D |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of Anaesthesiology and Critical Care,
Jawaharlal institute of postgraduate medical education and research, JIPMER campus road, dhanvantari nagar, Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9655999113 |
| Fax |
|
| Email |
aditi.dn19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyen Parida |
| Designation |
Professor and HOD |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of Anaesthesiology and Critical Care,
Jawaharlal institute of postgraduate medical education and research, JIPMER campus road, dhanvantari nagar, Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7708746042 |
| Fax |
|
| Email |
jipmersatyen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shindhujaa A D |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of Anaesthesiology and Critical Care,
Jawaharlal institute of postgraduate medical education and research, JIPMER campus road, dhanvantari nagar, Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9655999113 |
| Fax |
|
| Email |
aditi.dn19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of postgraduate medical education and research
Puducherry |
|
|
Primary Sponsor
|
| Name |
Jawaharlal institute of postgraduate medical education and research |
| Address |
JIPMER campus road, dhanvantari nagar, Gorimedu, Puducherry
605006 |
| 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 |
| DrShindhujaa A D |
Jawaharlal institute of postgraduate medical education and research |
Department of Anaesthesiology and Critical care, Institute block second floor, JIPMER campus, Dhanvantari nagar, Gorimedu, Puducherry
605006
Pondicherry
PONDICHERRY |
9655999113
aditi.dn19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES, JIPMER |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I340||Nonrheumatic mitral (valve) insufficiency, (2) ICD-10 Condition: I342||Nonrheumatic mitral (valve) stenosis, (3) ICD-10 Condition: I051||Rheumatic mitral insufficiency, (4) ICD-10 Condition: I050||Rheumatic mitral stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults undergoing elective mitral valve surgery |
|
| ExclusionCriteria |
| Details |
Patients already receiving mechanical ventilation
Patients already receiving ionotropes
Emergency surgery
Pregnancy
Chronic liver and kidney disease
IVC thrombus
Combined CABG and mitral valve surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of acute kidney injury and liver dysfunction in patients with mitral valve disease undergoing mitral valve surgery and VExUS score more than or equal to 1 with VExUS equal to zero |
Patient will be followed up until the patient is admitted in the post-operative ward or till POD-7
All patients enrolled in the study will be further followed up in OPDs and if not will be followed up with a telephone call at 30 and 60 days after the hospital discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the utility of BNP as risk predictor of composite of kidney and liver dysfunction after mitral valve surgery
To stratify the incidence of composite of kidney and liver dysfunction based on the grading of VExUS score
To evaluate the correlation between VExUS score and BNP
To identify correlation between individual component of VExUS and kidney and liver dysfunction |
|
| |
BNP evaluation is done before anaesthetic induction.
Patient will be followed up until the patient is admitted in the post-operative ward or till POD-7
All patients enrolled in the study will be further followed up in OPDs and if not will be followed up with a telephone call at 30 and 60 days after the hospital discharge. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
21/04/2026 |
| 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="2"
Months="0"
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
|
Recruitment of the patients will be done after the completion of CTRI registration. Patients satisfying the eligibility criteria will be included in the study after obtaining written informed consent. Before anaesthetic induction 2ml of venous blood sample will be obtained for BNP evaluation. Transthoracic echocardiographic examination and ultrasound scanning of liver and kidney will also be done before anaesthetic induction. Induction choice and insertion of pulmonary artery catheter will be based on the discretion of attending anaesthesiologist. Assessment of venous congestion will be performed using doppler based techniques. maximum size of IVC will be measured at the level of drainage of hepatic veins into IVC. Patients with IVC size of more than 2cms will be considered as having venous congestion and the patient will undergo further scanning of hepatic vein, portal vein and renal vein to quantify the intra-abdominal venous congestion. Those with IVC size less than 2cms will be labelled as VExUS score of 0 and no further scanning will be performed. Corresponding to the level of venous congestion VExUS score will be obtained. The primary outcome will be the composite of kidney and liver dysfunction. Acute kidney injury will be defined by the KDIGO criteria and acute liver injury will be defined as postoperative 1.5 times rise in ALT/AST/GGT during any time of index hospitalisation after cardiac surgery. Data concerning the performed procedure will be collected including duration of surgery, total fluid administration, duration of cardiopulmonary bypass, duration of cross-clamp time, urine output, blood loss, blood transfusion and vasoactive inotropic score will be obtained. The duration of mechanical ventilation, ICU stay, length of hospital stay and other major organ complications ( cardiovascular and neurological ) including mortality will be recorded during the hospital stay. All patients enrolled in the study will be further followed up in OPDs and if not will be followed up with a telephone call at 30 and 60 days after the hospital discharge to assess the rate of re-hospitalisation and death. |