| CTRI Number |
CTRI/2022/06/043435 [Registered on: 22/06/2022] Trial Registered Prospectively |
| Last Modified On: |
22/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Giving IV fluids in sick patients in ICU using ultrasound machine and studying its implications on renal function tests |
|
Scientific Title of Study
|
Utility of venous excess ultrasound (VEXUS score) in fluid resuscitated critically ill shock patients and its implications on development of acute kidney injury - A prospective observational study |
| Trial Acronym |
Utility of Venous excess ultrasound score (VEXUS score) in fluid resuscitated critically ill shock patients and its implications on development of acute kidney injury - A prospective observational stu |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil R |
| Designation |
Associate professor |
| Affiliation |
Kasturba medical college Manipal academy of higher education |
| Address |
Department of critical care medicine first floor ICU complex
casualty and trauma block Kasturba medical college Madhav Nagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
sunil.r@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil R |
| Designation |
Associate professor |
| Affiliation |
Kasturba medical college Manipal academy of higher education |
| Address |
Department of critical care medicine first floor ICU complex
casualty and trauma block Kasturba medical college Madhav Nagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
sunil.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil R |
| Designation |
Associate professor |
| Affiliation |
Kasturba medical college Manipal academy of higher education |
| Address |
Department of critical care medicine first floor ICU complex
casualty and trauma block Kasturba medical college Madhav Nagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
sunil.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Sunil R |
| Address |
Department of critical care medicine ICU complex First floor Casualty and trauma block Kasturba medical college Manipal |
| 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 |
| Dr Sunil R |
ICU 1 and ICU 2 |
Department of critical care medicine ICU complex First floor Casualty and trauma Block Kasturba medical college Madhav Nagar Manipal
Shimoga
KARNATAKA |
8095800142
sunil.r@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba Hospital Institutional Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N178||Other acute kidney failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Fluid resuscitated critically ill shock patients presenting with hypovolemia/sepsis
Patients with inferior venacaval diameter of more than 1.5 cm and less than 50 percent distensibility |
|
| ExclusionCriteria |
| Details |
patients with diagnosed right ventricular dysfunction with TAPSE less than 18 mm/radiologically diagnosed chronic liver disease/chronic kidney disease/right atrial myxoma or anatomical variations in the inferior venacaval system |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| acute kidney injury as defined by KDIGO |
48 hours after initiation of fluid resuscitation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mortality at the end of ICU stay or 28 days after ICU admission |
28 days after ICU admission |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
24/06/2022 |
| 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
|
No any |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Fluid resuscitation in critically ill ICU patients are very essential for initial stabilization of patients with hypovolemic/ septic shock. application of VEXUS ultrasound score during fluid resuscitation will lead to a eviidence based rationale fluid therapy also reducing the incidence of acute kidney injury in these patients |