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CTRI Number  CTRI/2024/05/067804 [Registered on: 22/05/2024] Trial Registered Prospectively
Last Modified On: 21/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparison of effectiveness of two ultrasound based grading systems for predicting kidney injury in patients undergoing heart surgery 
Scientific Title of Study   Prediction of Acute kidney injury with Venous excess ultrasound (VexUS) Scoring versus Renal Resistive index in patients undergoing on-pump Coronary Artery Bypass Grafting: 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  Shaswati Prusty 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Adult ICU (AICU) Department of Anaesthesiology and Critical care, Third floor D&T Block, All India Institute of Medical Sciences, Jodhpur, Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9502302412  
Fax    
Email  shaswati.prusty.98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shaswati Prusty 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Adult ICU (AICU) Department of Anaesthesiology and Critical care, Third floor D&T Block, All India Institute of Medical Sciences, Jodhpur, Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9502302412  
Fax    
Email  shaswati.prusty.98@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manoj Kamal 
Designation  Professor  
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  601, Cardiothoracic and Vascular Surgery OT Department of Anaesthesiology and Critical Care Sixth floor, D & T Block, AIIMS Jodhpur Jodhpur Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9414084584  
Fax    
Email  geetamanoj007@yahoo.co.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS) Jodhpur 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  AIIMS Jodhpur, Basni Phase 2, Jodhpur 342005 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manoj Kamal  All India Institute of Medical Sciences Jodhpur  601, Cardiothoracic and Vascular Surgery OT, Department of Anaesthesiology and Critical Care, Sixth floor, D&T Block, AIIMS Jodhpur Jodhpur RAJASTHAN Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 
9414084584

geetamanoj007@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients over 18 years of age, of either gender undergoing elective Coronary artery bypass grafting will be included in this study. 
 
ExclusionCriteria 
Details  In our study, patients with chronic renal dysfunction, those who underwent renal transplantation, individuals requiring emergency surgery, redo surgery, or combined procedures, those with non-sinus cardiac rhythm, and those in a critical state before surgery, including aborted surgery, sudden death, pre or intra-operative cardiac massage, patients on mechanical ventilation prior to surgery, as well as pregnant patients and those with renal artery stenosis, will be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the predictive accuracy of the VExUS score and renal resistive index in determining the occurrence of acute kidney injury (AKI) following coronary artery bypass grafting (CABG) procedures.  Vexus and RRI readings:
10 minutes before induction
Within 3 hours of shifting into the post operative area
Creatinine values to be considered 24 hourly till 72 hour post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the sensitivity and specificity of the VExUS score in predicting AKI post-CABG by comparing with post operative creatinine values according to KDIGO criteria.
Determine the sensitivity and specificity of the renal resistive index as a predictor of AKI in the same patient cohort by comparing with post operative creatinine values according to KDIGO criteria. 
Vexus and RRI readings:
10 minutes before induction
Within 3 hours of shifting into the post operative area
Creatinine values to be considered 24 hourly till 72 hour post operatively 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   01/06/2024 
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  

Acute Kidney Injury (AKI) in patients undergoing Coronary Artery

Bypass Grafting (CABG) is a significant post-operative concern, with

its incidence varying from 20-40%. 1-5% of these patients

end up requiring renal replacement therapy (RRT). It has been found

that serum creatinine as a marker of AKI usually rises late in the

post-operative period. Newer biological markers such as Neutrophil gelatinase

associated lipocalin (NGAL) and Kidney-Injury Molecule-1 (KIM-1) have

been tried in these settings, however, they are expensive and not

readily accessible.

Venous excess ultrasound (VExUS) and Renal resistive index (RRI) are

two ultrasound based scoring systems that have been developed measure

systemic venous congestion, and resistance in the renal arteries

respectively. These scoring systems have been found to be useful in

predicting AKI in patients undergoing cardiac surgeries. As the

facility of ultrasound is widely available in critical care settings,

calculation of these scores may help in early detection of AKI.

One baseline preoperative reading will be obtained for each of the aforementioned. One post-operative reading will be taken after the procedure, within 3 hours of shifting the patient to ICU. Aside from volume loading with crystalloids and colloid day 0 and mean urine output on days 1-2 of the postoperative ICU stay, other intraoperative data collection will include the duration of aortic clamping, transfusion and details of transfused products, urine output, mean arterial pressure, heart rate, PaCO2, lactates, blood saturation of O2 , serum total proteins, haematocrit, and the percentage of subjects receiving norepinephrine or dobutamine. The patients on whom satisfactory VExUS and RRI readings on dopplers cannot be obtained will be excluded from analysis. 

Assessment of kidney function: The patients’ preoperative serum creatinine values will be noted in the immediate post operative period, at 24 hours, 48 hours and 72 hours. The highest value found 72 hours after surgery will be the postoperative serum creatinine value that will be taken into consideration. For both genders, the normal range for serum creatinine measurements was 0.4–1.0 mg/dL and 0.6–1.3 mg/dL in men and women respectively. The KGIDO network criteria will define the occurrence of AKI.(27) During the post cardiac surgery ICU stay, postoperative urine production will be measured hourly. In patients developing AKI, treatment for the same will be started according to standard ICU protocols.

The corelation between the predictions of the gradings and development of post operative AKI will be assessed and compared.




 
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