Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05538637
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2022-09-06
Brief Title:
Is Mitral Velocity Time-integral a Marker of Preload-responsiveness in Patients With Acute Circulatory Failure
Sponsor:
Avicenna Military Hospital
Organization:
Avicenna Military Hospital
Study Overview
Official Title:
Reliability and Accuracy of Mitral Velocity Time-integral Variability With Passive Leg Raising as a Marker of Preload-responsiveness in Patients With Acute Circulatory Failure in the ICU
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this is to assess the reliability of the variability of the mitral velocity time-integral with passive leg raising to predict the fluid responsiveness in patients with acute circulatory failure in intensive care
Detailed Description:
Adult patients with acute circulatory failure will be included in the study An initial echocardiography is performed in patients placed in a semi-recumbent position On the apical views 4 and 5-chamber views the left ventricular outflow tract velocity time integral LVOT-VTI and mitral valve MV-VTI velocity time integral are measured baseline values Then a passive leg raise test is performed and the parameters LVOT-VTI and MV-VTI are measured again Preload-responsiveness is defined by an increase in LVOT-VTI of at least 10 In preload-responsive patients a fluid loading with 500 ml of 09 saline administered over 15 minutes is performed Immediately after fluid therapy the same parameters are recorded during a third echocardiography An increase of 10 or more of LVOT-VTI compared with baseline defines fluid responsiveness Patients are monitored using the standard of care practices Hemodynamic assessment includes repetitive echocardiographic examinations if needed In patients with shock invasive blood pressure is monitored with an arterial catheter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None