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CTRI Number  CTRI/2025/03/082970 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 26/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Comparison of an ultrasound parameter called renal resistivity index in trauma patients with and without hypotension admitted in intensive care unit 
Scientific Title of Study   Comparison of renal resistivity index in critically ill trauma patients with and without shock: 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  Anjuman Amina Mansoor 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology Pain Medicine and Critical Care All India Institute of Medical Sciences Ansari Nagar New Delhi

South
DELHI
110027
India 
Phone  9747701968  
Fax    
Email  anjuman.amina@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Yudhyavir Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology Pain Medicine and Critical Care 3nd floor Jai Prakash Narayan Apex Trauma Centre All India Institute of Medical Sciences Ansari Nagar New Delhi

South
DELHI
110027
India 
Phone  9811140057  
Fax    
Email  yudhyavir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anjuman Amina Mansoor 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology Pain Medicine and Critical Care All India Institute of Medical Sciences Ansari Nagar New Delhi


DELHI
110027
India 
Phone  9747701968  
Fax    
Email  anjuman.amina@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, India - 110029 
 
Primary Sponsor  
Name  Anjuman Amina Mansoor 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, 110029 
Type of Sponsor  Other [Self] 
 
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 
Anjuman Amina Mansoor  Trauma ICU 2 and 2A  Jai Prakash Narayan Apex Trauma Centre, AIIMS, Ansari Nagar, New Delhi
South
DELHI 
97747701968

anjuman.amina@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T794||Traumatic shock,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Adults aged 18 years or above within 24 hours of admission to trauma ICU 
 
ExclusionCriteria 
Details  Chronic kidney disease stage 3 and 4
Long standing hypertension
Diabetes mellitus
Renal artery stenosis
Congenital renal anomalies
Difficult abdominal window/Poor echogenicity
Expected ICU stay less than 72 hours
Pregnant women
9. Post-kidney transplant
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare RRI in patients with shock and without shock admitted to trauma ICU  Within 24 hours of admission 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the association between RRI and development of AKI  7 days 
To determine the relationship between RRI and serum lactate  7 days 
To determine the relationship between RRI and vasopressor use  7 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   31/03/2025 
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="2"
Months="0"
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  

Trauma remains one of the leading causes of morbidity and mortality worldwide, with critically ill trauma patients often facing a myriad of life-threatening complications, including acute kidney injury (AKI) and hemodynamic instability. Shock, defined as inadequate tissue perfusion leading to cellular dysfunction, is a common occurrence in trauma patients, and its management often requires immediate and precise interventions. The pathophysiology of shock involves complex hemodynamic changes that can adversely affect renal blood flow, leading to acute kidney injury (AKI) or worsening of pre-existing renal dysfunction. It is therefore critical to monitor renal perfusion accurately in these patients to guide therapeutic interventions. Among the markers of renal function, the renal resistivity index (RRI), measured via Doppler ultrasonography, has emerged as a promising tool for assessing renal perfusion and predicting adverse outcomes in critically ill patients.

Renal resistivity index (RRI) is an index derived from Doppler ultrasound assessment of intrarenal blood flow and reflects resistance to blood flow in renal vasculature. It is a non-invasive, bedside assessment. The specific utility in trauma patients remains less well defined. Recent studies have suggested that the RI may be a valuable predictor of AKI in trauma patients, particularly in those who present with hypoperfusion states such as shock. However, only few prospective studies have directly compared the renal RI between trauma patients with and without shock, which is essential for understanding its prognostic implications in this cohort.

This prospective observational study aims to compare the renal resistivity index in critically ill trauma patients with and without shock, to explore its utility as a biomarker for renal dysfunction and its potential as a prognostic tool. By analyzing RI values in the context of trauma-induced shock, this study seeks to provide valuable evidence to support its use in clinical practice and improve patient outcomes through early identification of renal compromise.


METHODOLOGY 

After obtaining ethics committee approval, student researcher will receive training for the measurement of RRI using Doppler ultrasound. Patients above the age of 18 years who are admitted in trauma ICU will be recruited within 24 hours of their admission. Informed written consent will be obtained from a legally appointed representative (LAR). Baseline characteristics and laboratory parameters will be noted, and patients will be classified as having or not having shock.

RRI assessment will be done for all patients and the readings will be repeated on days 2 and 3. Bedside ultrasound examination will be done with A 5MHz convex transducer, placed on the posterior axillary line to identify interlobular artery using the color Doppler. Pulse waveforms will be obtained and an image with three clear continuous waves is considered ideal. Average of RRI of right and left kidneys are obtained.

Patient will be followed up for 7 days to monitor urine output and serum creatinine to assess for development, duration and severity of AKI.

 
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