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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03753672
Other study ID # 2017-A03578-45
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 10, 2017
Est. completion date June 2019

Study information

Verified date February 2019
Source Hopital Antoine Beclere
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Passive leg raising (PLR) is routinely used to predict preload responsiveness in critically ill patients. However, real-time measurements of cardiac output are required to assess its effects. Some authors have suggested that in fluid non-responders, central venous pressure (CVP) increased markedly. By analogy with the CVP rules proposed by Weill et al to assess a fluid challenge, it has been hypothesized that an increase in CVP ≥ 5 mmHg during PLR can predict preload unresponsiveness.

Objective Investigation of whether an increase in CVP ≥ 5 mmHg during PLR predict preload unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the flow in the left ventricular outflow tract by more than 10% (4).

Methods Critically ill patients with a central venous catheter in place and for whom the physician decided to test preload responsiveness by PLR were prospectively included. Transthoracic echocardiography was performed to obtain VTI. The CVP and VTI were measured before and during PLR.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date June 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- ADULTS

- Patients presenting with shock or other signs of circulatory failure (tachycardia, oliguria)

- Need for the physician to test preload responsiveness

- Patients already equipped by a central venous catheter for the measurement of CVP

Exclusion Criteria:

- patients<18 years old

- pregnancy

- instaility justifying rapid increase in cathecolamines

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
preload responsiveness
We investigated whether an increase in CVP = 5 mmHg during PLR predict preload unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the flow in the left ventricular outflow tract by more than 10%

Locations

Country Name City State
France Hamzaoui Olfa Clamart

Sponsors (1)

Lead Sponsor Collaborator
Hopital Antoine Beclere

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary the predictive value of changes in CVP to determine preload responsiveness Systolic, diastolic and mean arterial pressure will be assessed before and after the PLR test ONE MINUTE TEST
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