| CTRI Number |
CTRI/2024/07/070461 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To find the effect of giving fluid based on ultrasound versus clinician based fluid management on the incidence of kidney injury adult burns patients |
|
Scientific Title of Study
|
Comparison of Venous Excess Ultrasound Grading (VEXUS) based fluid management with standard fluid management in critically ill adult burn injury patients post initial resuscitation - a randomized controlled 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 |
AJEET VISWANATH TP |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 5011
5th floor Administrative block
Dept of Anaesthesiology Pain Medicine & Critical Care
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9176591005 |
| Fax |
|
| Email |
avtp1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AJEET VISWANATH TP |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 5011
5th floor Administrative block
Dept of Anaesthesiology Pain Medicine & Critical Care
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9176591005 |
| Fax |
|
| Email |
avtp1989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhavana K |
| Designation |
Senior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 5011
5th floor Administrative block
Dept of Anaesthesiology Pain Medicine & Critical Care
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9600717490 |
| Fax |
|
| Email |
bhavanakayarat27@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Ansari Nagar
New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
Ansari Nagar
New Delhi 110029 |
| 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 |
| Dr Ajeet Vishwanath TP |
All India Institute of Medical Sciences, New Delhi |
Room no 5011
5 th floor Administrative block
Dept of Anaesthesiology Pain Medicine & Critical Care
South
DELHI |
9176591005
avtp1989@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: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Post initial fluid resuscitation, patients will be monitored clinically for the need for diuretics and albumin. Administration of diuretics, colloids or albumin will be as per the clinician’s discretion. No ultrasonographic assessment will be done in the control arm. |
| Intervention |
VEXUS |
Post initial fluid resuscitation, patients will undergo ultrasonographic assessment of hepatic vein ,portal vein and renal vein and the Grade of VExUS will be computed by a clinician in the ICU with the requisite ultrasonographic experience, using a curvilinear (5-10 MHz) probe at the following time points 12, 24, 36, 48 and 60 hours of the first scan. If the VExUS grade of congestion is noted to be grade 2 or higher, VExUS based fluid therapy will be initiated and administration of diuretics, colloids or Albumin will be done as per the clinician’s discretion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Greater than or equal to 20% and less than 90% body surface area burns admitted in the ICU within 24 hours of burn injury
|
|
| ExclusionCriteria |
| Details |
Pre existing kidney disease, severe portal hypertension, severe heart failure or severe lung disease
Pregnant patients
Patients with BMI of more than 30
Abdominal pathology interfering with the USG views
Significant tricuspid or pulmonary regurgitation
Patients with associated polytrauma
Patients denying or withdrawing consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of AKI at 7 days post burn resuscitation |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in SOFA score |
3 days |
| Incidence of mortality |
28 days |
| Ventilator free days |
28 days |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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
|
Fluid resuscitation in burn injury patients is the first and most vital cog in the ICU management of these patients. Several formulae are in use to calculate the volume of fluid to be given to cover the losses, including Parkland’s formula, and Modified Brooke’s formula . However, most of these formulae were found to overpredict the volume deficit among burn injury patients, thus leading to volume overload. Fluid creep is a common manifestation of burn injury resuscitation and has been found to present with several unwanted complications in patients(2). These include pulmonary edema, peripheral edema, decreased wound healing, compartment syndrome leading to increased ICU days and poorer outcomes(3). Another dreaded complication of fluid overload is AKI (4)Thus, monitoring adequacy of fluid resuscitation becomes essential. Current standard methods of monitoring fluid status include urine output, lactate clearance, central venous pressure, pulse volume and blood pressure(5). The disadvantage with these methods is the subjective difference between each patient as well as between clinicians, which makes it harder to arrive at an appropriate target. Newer methods of assessing fluid status such as the Venous excess ultrasound score (VEXUS) have shown to be promising in terms of their accuracy and sensitivity in predicting fluid overload and AKI(6,7). This randomised controlled study is aimed at comparing the incidence of AKI in critically ill burn injury patients who undergo VExUS based fluid management compared to standard fluid management, post burn resuscitation, at the end of 1 week. |