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

• Conditions: Cardiovascular Shock
• Interventions: Diagnostic Test: preload responsiveness

• Registration Number: NCT03753672
• Lead Sponsor: Hopital Antoine Beclere

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-10
• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-23
• Study First Posted: 2018-11-27
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-22
• Primary Completion: 2019-03
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
preload responsive	preload responsiveness	defined as an increase in Velocity time integral of the sub-aortic flow greater or equal to 10%
preload unresponsive	preload responsiveness	defined as an increase in Velocity time integral of the sub-aortic flow lower than 10%

Primary Outcome Measures

Name	Time	Method
the predictive value of changes in CVP to determine preload responsiveness	ONE MINUTE TEST	Systolic, diastolic and mean arterial pressure will be assessed before and after the PLR test

Trial Locations

Locations (1)

Hamzaoui Olfa; 🇫🇷 Clamart, France