Central Venous Pressure (CVP) Changes do Not Predict Preload Unresponsiveness

Cardiovascular Shock Clinical Trial

Official title:

Central Venous Pressure (CVP) Changes do Not Predict Preload Unresponsiveness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03753672
• Other study ID #: 2017-A03578-45
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Shock
• Shock, Cardiogenic

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