| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T794||Traumatic shock, |
|
|
Intervention / Comparator Agent
|
|
|
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. |