| 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
|
|
|
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 |
1 |
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
|
|
|
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. |