| CTRI Number |
CTRI/2023/08/056049 [Registered on: 02/08/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Fluid overload assessment in Heart Failure |
|
Scientific Title of Study
|
Combination of VEXUS score (Inferior Vena Cava Diameter, Hepatic Venous Flow, and Portal Vein Pulsatility Index) in correlating Acute Kidney Injury in patients with Left Heart Failure: 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 |
Dr Nitika Yadav |
| Designation |
DrNB Resident |
| Affiliation |
Medanta, The Medicity, Gurgaon |
| Address |
Medanta Institute of Critical Care and Anaesthesiology,ICU 11, 3rd Floor
Medanta, The Medicity, Gurgaon, Sector 38, Gurgaon, Haryana
Gurgaon
HARYANA
122001
India |
| Phone |
7290897402 |
| Fax |
|
| Email |
nitikayadavmbbs050191@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Tyagi |
| Designation |
Associate Consultant- Critical Care |
| Affiliation |
Medanta, The Medicity, Gurugram |
| Address |
Medanta Institute of Critical Care and Anaesthesiology
Medanta - The Medicity, Gurugram, Sector 38, Gurugram, Haryana
Gurgaon
HARYANA
122001
India |
| Phone |
8860037475 |
| Fax |
|
| Email |
poojatyagi1919@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitika Yadav |
| Designation |
DrNB Resident |
| Affiliation |
Medanta, The Medicity, Gurugram |
| Address |
Medanta Institute of Critical Care and Anaesthesiology
Medanta - The Medicity, Gurugram, Sector 38, Gurugram, Haryana
Gurgaon
HARYANA
122001
India |
| Phone |
7290897402 |
| Fax |
|
| Email |
nitikayadavmbbs050191@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medanta, the Medicity, Sector 38, Gurugram, Haryana 122001, India |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Nitika Yadav |
Medanta, The Medicity |
Medanta Institute of Critical Care and Anaesthesiology
Medanta - The Medicity, Sector 38, Gurugram
Gurgaon
HARYANA |
7290897402
nitikayadavmbbs050191@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee (MIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I501||Left ventricular failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Age > 18 years
2. Patients presenting to ICU with Left Heart failure with reduced ejection fraction(EF<40%)
3. Patients meeting NT-proBNP cut-off for diagnosis of heart failure(age<50 years-450pg/ml, age 50 to 75 years-900pg/ml, age >75 years-1800pg/ml)
4. Patients having AKI as per KDIGO criteria
|
|
| ExclusionCriteria |
| Details |
1.known cases of cirrhosis with portal hypertension, chronic kidney disease, inadequate window, IVC thrombus, status asthmaticus, major cardiac arrhythmia, pregnancy, AKI due to sepsis or drug induced |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the correlation between serial VEXUS score & AKI in patients with heart failure |
48 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assess correlation between VEXUS score &
fluid balance
|
48 HOURS |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
16/08/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
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
|
Acute left heart failure is associated with volume overload or venous congestion. Fluid overload leads to venous congestion, thereby increasing venous pressure and theoretically increasing the backpressure and reducing renal blood flow, and since kidneys are encapsulated organs it might make them more sensitive to this effect. Apart from increased mortality, venous congestion can cause end- organ damage, thereby increasing the incidence of acute kidney injury (AKI), length of stay in ICU, and duration of mechanical ventilation. Clinical signs of fluid overload like peripheral edema and ascites are poor indicators of fluid overload in the ICU setup. In view of lack of reliable peripheral signs of venous congestion, objective determination of the same is the need of the hour to aid key clinical decisions like fluid restriction and diuretic administration. |