| CTRI Number |
CTRI/2024/06/069236 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Fluid overload assessment in heart failure |
|
Scientific Title of Study
|
Correlation of venous excess ultrasound score with acute kidney injury in patients with left heart failure |
| 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 Milind Manvar |
| Designation |
DrNB Resident |
| Affiliation |
Medanta, The Medicity, Gurgaon |
| Address |
ICU 9, 10, 11, and 12 Medanta the medicity Sector 38 Gurgaon Haryana 122001, India
Gurgaon
HARYANA
122001
India |
| Phone |
7470585760 |
| Fax |
|
| Email |
manvar.milind@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 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 |
|
|
Source of Monetary or Material Support
|
| Institute of critical care and anesthesiology Medanta the medicity sector 38 Gurgaon Haryana 122001 India |
|
|
Primary Sponsor
|
| Name |
Medanta the Medicity |
| Address |
ICU 9 10 and 11 12 Medanta the medicity Sector 38 Gurgaon Haryana 122001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Milind Manvar |
Medanta the medicity |
Institute of critical care and Anesthesia Medanta the medicity Sector 38 Gurgaon Haryana 122001 Gurgaon HARYANA
Gurgaon
HARYANA
Gurgaon
HARYANA |
7470585760
manvar.milind@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 above 18 years
2 Patients presenting to ICU with Left Heart failure with reduced ejection fraction EF less than 45 percent
3 Patients meeting NT pro BNP cut off for diagnosis of heart failure age less than 50 years 450 pg per ml age 50 to 75 years 900 pg per ml age greater than 75 years 1800 pg per ml
4 Patients having AKI as per KDIGO criteria
|
|
| ExclusionCriteria |
| Details |
1 Patients having chronic liver diseases with portal hypertension
2 IVC thrombosis
3 Patients having COPD with cor pulmonale
4 Major valvular abnormalities
5 Heart failure due to arrythmias
6 Pregnant females
7 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 and 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="80"
Sample Size from India="80"
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)
|
01/07/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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. |