| 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 |
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Type of Study
|
Cohort Study |
| Study Design |
Other |
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Public Title of Study
|
Comparison of effectiveness of two ultrasound based grading systems for predicting kidney injury in patients undergoing heart surgery |
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Scientific Title of Study
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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 |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS) Jodhpur |
|
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Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
AIIMS Jodhpur, Basni Phase 2, Jodhpur 342005 |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Jodhpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
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Intervention / Comparator Agent
|
|
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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.
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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 |
|
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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 |
|
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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" |
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Phase of Trial
|
N/A |
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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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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