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CTRI Number  CTRI/2024/09/073755 [Registered on: 11/09/2024] Trial Registered Prospectively
Last Modified On: 07/09/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Renal resistive index in predicting acute kidney injury in neurocritical care 
Scientific Title of Study   Role of renal resistive index in predicting AKI in Traumatic brain injury patients admitted to neuro-intensive care unit- 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  Rohini Surve 
Designation  Additional professor 
Affiliation  National Institute of Mental Health and Neurosciences, Bengaluru 
Address  Room number 1, 3rd floor, Department of Neuroanesthesia and Neurocritical care, Neurosciences faculty building, National Institute of Mental Health and Neurosciences, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone    
Fax    
Email  rohinigondhule@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Archana Sharma 
Designation  Senior resident 
Affiliation  National Institute of Mental Health and Neurosciences, Bengaluru 
Address  Room number 1, 3rd floor, Department of Neuroanesthesia and Neurocritical care, Neurosciences faculty building, National Institute of Mental Health and Neurosciences, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9820454737  
Fax    
Email  drarchana7anesthesia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Archana Sharma 
Designation  Senior resident 
Affiliation  National Institute of Mental Health and Neurosciences, Bengaluru 
Address  Room number 1, 3rd floor, Department of Neuroanesthesia and Neurocritical care, Neurosciences faculty building, National Institute of Mental Health and Neurosciences, Bengaluru


KARNATAKA
560029
India 
Phone  9820454737  
Fax    
Email  drarchana7anesthesia@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Medical Sciences, Bengaluru 
 
Primary Sponsor  
Name  National Institute of Mental Health and Neurosciences Bengaluru 
Address  3rd floor, Department of Neuroanesthesia & Neurocritical care, Neurosciences faculty building, National Institute of Mental Health and Neurosciences, Bengaluru 
Type of Sponsor  Research institution and hospital 
 
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 
Archana Sharma  Neurocentre ICU and Emergency ICU, National Institute of Mental Health and Neurosciences, Bengaluru
Bangalore
KARNATAKA 
9820454737

drarchana7anesthesia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES P.B. NO.2900, HOSUR ROAD, BENGALURU - 560 029 (INDIA)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S069||Unspecified intracranial injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil (observational study) No option to select NIL in the "TYPE" of study value. please look into it. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Adult patients admitted to ICUs
2. With Traumatic brain injury
3. Both genders, male and female 
 
ExclusionCriteria 
Details  1. Patients with pre-existing CKD, Renal artery stenosis, polycystic kidney disease or a single kidney
2. Patients with poor window for ultrasonic visualization
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To predict occurrence of AKI using the Renal Resistive Index (RRI) in patients with traumatic brain injury  diagnosis of acute kidney injury during hospital stay ( Day 1,3,5,7 of ICU admission) 
 
Secondary Outcome  
Outcome  TimePoints 
Develop cut-off of RRI for prediction of AKI using KDIGO criteria
Finding association with neurological outcome at discharge from ICU & hospital (using GOSE) with RRI
Finding association of in-hospital mortality with RRI
Finding association of length of ICU & hospital stay with RRI 
until patient is discharged or deceased 
 
Target Sample Size   Total Sample Size="95"
Sample Size from India="95" 
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)   01/10/2024 
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 Yet Recruiting 
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  

Study Protocol:

Once the patient meets the inclusion criteria, written informed consent will be obtained, and the following data will be recorded.

 

Data Collection:

Patient-related details: Demographics (Age, Gender, Height, Weight), pre-existing co-morbidities with duration and medication details, presenting symptoms, diagnosis, and radiological imaging findings, details of surgical procedure (if any). 

On admission to ICU: Vitals, Glasgow Coma Scale (GCS), arterial blood gases (ABG), APACHE II score, and qSOFA score will be noted

Details noted during the first 7 days of the ICU stay: 

Serum creatinine & electrolytes, blood glucose levels, hemoglobin, TLC, any other abnormal laboratory values 

Daily input and output 

Use of hyperosmolar fluids, diuretics, ACE inhibitors, ARBs, anti- edema drugs

Details of mechanical ventilation 

Sedation (if required – type and dosing)

Need of inotropes (drugs and dosage)

 

POCUS examination of kidneys for renal resistive index will be done once a day on Day 1,3,5, and 7 of admission to the ICU.  A 2-5MHz array probe will be used and a longitudinal view of the kidney in B-mode will be obtained via posterolateral approach, and vessels will be localized using color doppler mode. An interlobar or arcuate artery will be identified, and using Pulse-wave Doppler, the peak systolic velocity (Vmax) and minimum diastolic velocity (Vmin) will be recorded. 

Renal resistive index (RRI) will be calculated as-

(Vmax-Vmin)/Vmax. 

An average of three measurements will be recorded for bilateral kidneys.

Newer USG machines, which are now available in our ICUs, provide an automated derivation of RRI where one needs to select the RRI calculation option once the renal vessels are identified and it will provide you a value of RRI via preinstalled automated formulas.

Both these methods will be used to calculate the RRI for this study.

 

AKI will be defined as per Acute Kidney Injury Working Group of KDIGO (Kidney Disease: Improving Global Outcomes):

·      any rise of >0.3 mg/dl in serum creatinine within 48 hours or 

·      a rise in serum creatinine 1.5 times than baseline within 7 days or

·      urine output <0.5ml/kg/hour for 6 consecutive hours

 

AKI will be considered transient if serum creatinine declines by 50% or more accompanied by normal urine output for the age and weight within 3 days of onset, whereas persistent AKI will be defined by a persistent rise in serum creatinine or declining urine output for >72 hours or if patient needs renal replacement therapy.

 
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