| CTRI Number |
CTRI/2020/10/028717 [Registered on: 29/10/2020] Trial Registered Prospectively |
| Last Modified On: |
28/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to evaluate the correlation between renal oxygen saturation and acute kidney injury during adult cardiac surgery |
|
Scientific Title of Study
|
A randomised control trial to evaluate renal oxygen saturation as a guide to altered renal perfusion in adult cardiac surgery patients.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Richa Malik |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Cardiac Anesthesia, AIIMS Rishikesh, Uttarakhand
Not Applicable
N/A
249203
India |
| Phone |
07037762589 |
| Fax |
|
| Email |
richamalik99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Cardiac Anesthesia, AIIMS Rishikesh, Uttarakhand
Not Applicable
N/A
249203
India |
| Phone |
9340482058 |
| Fax |
|
| Email |
ajaymishra0701@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Richa Malik |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Cardiac Anesthesia, AIIMS Rishikesh, Uttarakhand
Not Applicable
N/A
249203
India |
| Phone |
07037762589 |
| Fax |
|
| Email |
richamalik99@gmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rishikesh |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
Veerbhadra Road, Rishikesh, Uttarakhand |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Richa Malik |
AIIMS Rishikesh |
Department of Cardiac Anaesthesia, AIIMS, Rishikesh, Uttarakhand, Pin 249203
|
07037762589
richamalik99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aiims rishikesh |
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: I050||Rheumatic mitral stenosis, (2) ICD-10 Condition: I051||Rheumatic mitral insufficiency, (3) ICD-10 Condition: I052||Rheumatic mitral stenosis with insufficiency, (4) ICD-10 Condition: I058||Other rheumatic mitral valve diseases, (5) ICD-10 Condition: I05-I09||Chronic rheumatic heart diseases, (6) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (7) ICD-10 Condition: Q239||Congenital malformation of aorticand mitral valves, unspecified, (8) ICD-10 Condition: I34||Nonrheumatic mitral valve disorders, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
adult cardiac surgical patients |
in the “intervention†arm, an intervention will be instituted, as soon as a fall in renal rSO2 will be seen below values of 20% from the baseline; in the following sequence:
1. Vasopressors ( Phenylephrine boluses or Noradrenaline infusion ) or 2. Increasing pump flow to maintain MAP 60 mm Hg or
3. Blood transfusion to keep hematocrit 25%
4. In patients with persistent rSO2 below treatment threshold, FiO2 will be increased |
| Comparator Agent |
adult cardiac surgical patients
|
a control group with no intervention |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group of 18 to 60 years of age, of either sex
ASA II - III patients
Patients posted for elective cardiac surgery including CABG, valve surgery, combined CABG and valve surgery, under cardiopulmonary bypass
Patients willing to give informed and written consent |
|
| ExclusionCriteria |
| Details |
Patients refusal
Emergency surgery
Aortic surgery
Preoperative renal dysfunction, defined as S.Cr > 1.5mg/dl or end-stage renal disease
Preoperative low cardiac output state, defined as Left Ventricle Ejection Fraction ( LVEF ) < 30%
Body Mass Index ( BMI ) > 30kg/m2
Post renal transplant status
Off pump coronary artery bypass grafting surgery Skin to renal capsule distance > 40 mm |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of intervention based on renal rSO2 monitoring in prevention of AKI in post operative period in elective adult cardiac surgical patients |
renal saturation monitoring will be done intraoperatively and efficacy of the intervention will be assessed by measuring serum creatinine postoperatively for 2 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the change in renal rSO2 during intra-operative period as predictor of change in serum creatinine in post-operative period in elective adult cardiac surgical patients.
2.To determine the change in eGFR
3.Mean Duration Of Mechanical Ventilation
4.Mean Duration of ICU stay
5.In Hospital Mortality, in first 48 hours postoperative period
6.Incidence of renal replacement therapy in first 48 hours postoperative period |
1 year |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/10/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
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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
|
Hypothesis of this study is that intraoperative monitoring of renal rSO2 with
measures to minimise the decline from baseline rSO2, would result in lesser rise
in serum creatinine values in the postoperative period for elective cardiac
surgical patients, undergoing CABG, valve surgery or combined surgeries.
|