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CTRI Number  CTRI/2021/11/037856 [Registered on: 08/11/2021] Trial Registered Prospectively
Last Modified On: 07/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Trans-esophageal echocardiography derived renal artery doppler indices to assess post operative development of acute kidney injury in beating heart bypass surgery. 
Scientific Title of Study   Study of Renal Resistive Index to Assess Postoperative Development of Acute Kidney Injury in Patients Undergoing Off Pump CABG. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nazmeen I Sayed 
Designation  Associate professor 
Affiliation  Lokmanya Tilak Municipal Medical college  
Address  Room no 324 Anaesthesiology Department college building 4 th floor lokmanya Tilak Municipal Medical college Sion Mumbai

Mumbai
MAHARASHTRA
22
India 
Phone  09819507875  
Fax    
Email  drnazmeensayed@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nazmeen I Sayed 
Designation  Associate professor 
Affiliation  Lokmanya Tilak Municipal Medical college  
Address  Room no 324 Anaesthesiology Department college building 4 th floor lokmanya Tilak Municipal Medical college Sion Mumbai

Mumbai
MAHARASHTRA
22
India 
Phone  09819507875  
Fax    
Email  drnazmeensayed@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nazmeen I Sayed 
Designation  Associate professor 
Affiliation  Lokmanya Tilak Municipal Medical college  
Address  Room no 324 Anaesthesiology Department college building 4 th floor lokmanya Tilak Municipal Medical college Sion Mumbai

Mumbai
MAHARASHTRA
22
India 
Phone  09819507875  
Fax    
Email  drnazmeensayed@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical college and General Hospital 
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal medical college 
Address  Lokmanya Tilak Municipal Medical college and General Hospital  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Shakuntala Basantwani   Lokmanya Tilak Municipal Medical college and General Hospital  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nazmeen I Sayed   CVTS OT, Lokmanya Tilak Municipal Medical college and General Hospital   Room No 304 Anaesthesiology Department fourth floor College Building LTMMC & LTMGH Dr. Babasaheb Ambedkar Road Sion (West) Mumbai - 400022
Mumbai
MAHARASHTRA 
09819507875

drnazmeensayed@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Commitee Human Research ,LTMMC & LTMGH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I222||Subsequent non-ST elevation (NSTEMI) myocardial infarction, (2) ICD-10 Condition: I220||Subsequent ST elevation (STEMI) myocardial infarction of anterior wall, (3) ICD-10 Condition: I221||Subsequent ST elevation (STEMI) myocardial infarction of inferior wall, (4) ICD-10 Condition: I228||Subsequent ST elevation (STEMI) myocardial infarction of other sites,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  diagnostic test, renal artery doppler   transesophageal echocardiography guided measurement of Renal Resistive index 
Comparator Agent  not applicable   single arm study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with Age more than 18yrs undergoing elective off pump CABG 
 
ExclusionCriteria 
Details  Emergency Surgery
Known case of renal artery stenosis
Arrhythmias
Patients with preoperative IABP requirement
Patients on hemodialysis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Renal Resistive index more than or equal to 0.74 indicates post operative development of acute kidney injury
Acute renal injury will be defined as an abrupt (within 48 h) absolute increase in the serum creatinine concentration of ≥0.3 mg/dL from baseline, a percentage increase in serum creatinine of ≥50%, or oliguria of less than 0.5 mL/kg/hr for more than 6 h 
48 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
raise in central venous pressure along with renal resistive index more than or equal to 0.74 indicates postoperative development of acute renal injury  48 hours after surgery 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="29" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/11/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/06/2022 
Estimated Duration of Trial   Years="0"
Months="2"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
not published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drnazmeensayed@gmail.com].

  6. For how long will this data be available start date provided 11-08-2022 and end date provided 11-08-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Aim:

TO STUDY PREDICTIVE VALUE OF RENAL RESISTIVE INDEX FOR DEVELOPMENT OF   POSTOPERATIVE ACUTE KIDNEY INJURY IN PATIENTS UNDERGOING OFF PUMP CABG

 

 Objectives:

Primary objective :

a)     To document the change in RRI following coronary  anastomosis in off pump CABG 

b)    To determine predict value of RRI for development of postoperative AKI

Secondary  objective

1.     To document the change in RRI and CVP following coronary  anastomosis in off pump CABG and   determine their combined value to predict development of postoperative AKI

2.     To correlate the changes in RRI during position of the heart for circumflex (lateral) and PDA (inferior) anastomosis in off pump CABG with changes cardiac output, cardiac index, mean arterial pressure and CVP

 

Study Methodology :

TEE probe is routinely inserted after induction of anaesthesia .  We  use the TEE probe to scan the kidney and measure the renal resistive index in the left kidney.

The TEE probe is advanced approximately 30 cm from the upper incisor teeth, and a standard midesophageal 4-chamber view is obtained. Starting from the 4-chamber view, the probe is advanced a further 8 to 10 cm to lead it through the short abdominal part of the oesophagus eventually into the stomach and anteflexed to obtain a midpapillary transgastric short-axis (TG SAX) view. 

STEP 1:  TG SAX view is obtained . •

STEP 2: The probe   is rotated 90 to 270 degrees toward the LEFT until the SAX view of the   descending aorta is imaged. The aorta lies   anterior to the oval hypoechogenic vertebral body

 STEP 3: The probe is advanced 4–6 cm following the aorta to the origin of the left renal artery Colour flow doppler is used  to image the blood flow in left renal vessels.

 STEP 4 : Pulse wave doppler is used to measure the RRI as follows :

 

 

Use of ionotropes , fluids or vasodilators to maintain haemodynamic stability is managed by the concerned anaesthesiologists. After steadying of hemodynamic changes due to positioning and stabilization of the heart with octopus for anastomosis of obtuse marginal (OM) and posterior descending artery (PDA), change in the left kidney RRI are noted. Final left RRI is  recorded after protamine reversal of heparin.

Systemic hemodynamic changes are manifested in both the kidneys .As left kidney is easy to scan we measure only left RRI.

TEE guided Left Renal Resistive Index (RRI) will be  measured as follows

a.     Baseline T0 :measured after induction and steady state haemodynamics for 5 mins

b.     During anastomosis of OM -T1

c.     During anastomosis of PDA-T2

d.     After reversal of heparin with protamine .-T3

AKI will be  diagnosed using criteria proposed by Acute Kidney Injury Network (AKIN) as  an abrupt (within 48 h) absolute increase in the serum creatinine concentration of ≥0.3 mg/dL from baseline, a percentage increase in serum creatinine of ≥50%, or oliguria of less than 0.5 mL/kg/hr for more than 6 h14 AKI will be  defined using the AKIN criteria by comparing the highest serum creatinine within 48 h after surgery with preoperative serum creatinine

 

Recovery from AKI will be defined as a 50 percent decrease in serum creatine or return of serum creatine to its baseline value.

 

.

Patients who meet the AKIN criteria for AKI are classified as “AKI”, whereas those who do not are  classified as “no AKI”.

 For analysis study population will be grouped as follows

1.     No AKI

2.     Transient AKI:

Transient AKI will be defined as recovery from AKI within 3 days after surgery. Persistent AKI : will be defined as persistent elevation of serum creatine   after  3 days.

 

Intraoperative Parameters recorded will be

1.     Left RRI

2.     Cardiac output and cardiac index as measured by flowtrac

3.     Mean arterial pressure (MAP)

4.     CVP

                        Post operative parameters recorded will be

                                   Sr creatine and   Urine out put :for 3 days if no AKI ; or till 5 days if AKI develops.

 

Statistical analysis

Results will be expressed as median with range,  number with proportion (%), percentage with standard deviation as appropriate. Pearson’s  test will be used to study the correlations. A receiver-operating characteristic curve (ROC) will be generated for RRI in each AKI group to test the significance of RRI as a diagnostic tool.

 
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