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CTRI Number  CTRI/2023/06/053906 [Registered on: 15/06/2023] Trial Registered Prospectively
Last Modified On: 13/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   Is there any difference between the renal resistive index between postoperative shock versus non shock patients? 
Scientific Title of Study   An observational study to compare the renal resistive index in postoperative shock versus non-shock patients 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Maheswari S 
Designation  PG Resident 
Affiliation  lady hardinge medical colledge affiliated to university of delhi 
Address  Department of Anaesthesiology Main OT complex Lady Hardinge Medical Colledge

New Delhi
DELHI
110001
India 
Phone  9999001256  
Fax    
Email  mahilavu2098@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil Kumar 
Designation  Professor, Department of Anaesthesia 
Affiliation  lady hardinge medical colledge affiliated to university of delhi 
Address  Department of Anaesthesiology Main OT complex Lady Hardinge Medical Colledge

Central
DELHI
110001
India 
Phone  8084660100  
Fax    
Email  drkumaranil@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Anil Kumar 
Designation  Professor, Department of Anaesthesia 
Affiliation  lady hardinge medical colledge affiliated to university of delhi 
Address  Department of Anaesthesiology Main OT complex Lady Hardinge Medical Colledge

Central
DELHI
110001
India 
Phone  8084660100  
Fax    
Email  drkumaranil@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Lady Hardinge Medical College and Associated Hospitals 
 
Primary Sponsor  
Name  Department of Anaesthesiology, Lady Hardinge Medical College and Associated Hospitals 
Address  Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India 
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 
Maheswari S  Lady Hardinge Medical College and Associated Hospitals  Main Intensive Care Unit Department of Anesthesiology Ground Floor Near Main OT complex Delhi 110001 India
Central
DELHI 		 9999001256

mahilavu2098@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: P00-P96||Certain conditions originating in the perinatal period, (3) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (4) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  In shock group:
1. More than 18year old
2. Either sex
3. Requiring Intensive care admission and diagnosed with shock.

In Non-shock group:
1. More than 18year old
2. Either sex
3. Requiring Intensive care admission due to any reason other than shock
postoperatively 
 
ExclusionCriteria 
Details  1.Patients with renal insufficiency (eGFR <90ml/min) by Modification of Diet in
Renal Disease criteria.16
2.Patients with dialysis dependency
3. Patients with monokidney
4. Patients after renal transplant. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean difference of RRI between shock & non-shock patients  72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Sensitivity & specificity, Positive Predictive Value, Negative Predictive Value of RRI to
predict AKI in both the groups.
Area under the receiver operator characteristic curve shall be calculated to determine the cut
off value of RRI to predict AKI. 		 72 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   27/06/2023 
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="4"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Study will be conducted after the approval from the institutional ethical committee and
registration with Clinical Trials Registry of India (CTRI). Patients fulfilling the inclusion
criteria will be recruited for the study. A written and informed voluntary consent will be
obtained from the patient or next to kin, after carefully explaining the procedure, its benefits
and risks in his/her vernacular. Any postoperative patient who will develop hypotension in ICU
will be treated as per standard protocol and if hypotension will not be corrected within first
three hour of resuscitation, then the first value of renal resistive index will be measured between
first 3 to 6 hours of development of shock. Renal resistive index of the patients will be measured
with SonositeTM Edge II Total portable ultrasound machine and P19 phased curvilinear array
probe (2-5MHz) in supine position. The probe will be placed in posterior axillary line to get an
image of kidney. RRI will be measured from interlobar or arcuate arteries adjacent to medullary
pyramids. Three sequential reading from upper, median, lower lobe will be taken and its
average will give the final RRI. RRI is calculated by the formula:
RRI= (peak systolic velocity-end diastolic velocity)/peak systolic velocity
IVC measurement will be done in short axis view with phased array probe(1-5MHz) in supine
position in short axis view. The difference between IVC measurement during expiration (IVCE)
and IVC measurement during inspiration (IVCI) and IVC collapsibility index will be calculated
as IVCE-IVCI/IVCE to assess intravascular volume in relation to the central venous pressure.
Cardiac Index (CI), Pulse Pressure Index (PPI) will be seen from Edward VIGILEO monitor
and transducer, connected to FLOTRAC sensor. FLOTRAC sensor will be connected to the
radial artery catheter of the patients The sensor will be placed at the level of right atrium before
pressure equilibration(zeroing).
Following details will be noted from patients:
1. Age
2. Gender
3. APACHE II score
4. SOFA score
5. Inferior vena cava diameter and collapsibility with respiration.
6. Risk factors for AKI like sepsis, hypotension & diabetes.
7. Renal function assessed with pre admission creatinine, eGFR
8. Urinary indices like FENa, FEurea, albumin/creatinine ratio
9. Daily measurement of change in hemodynamic parameters like HR, MAP, PPI, CVP, CI,
vasopressors dose, serum lactate, serum urea, serum creatinine, urine output and RRI up to 3
days
 
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