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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Shock
• Intervention / Treatment: Diagnostic test: preload responsiveness

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92141
    • Recruiting
    • Hamzaoui Olfa
    • Contact: OLFA HAMZAOUI, MD; Phone Number: 0033145374957; Email: olfa.hamzaoui@abc.aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hopital Antoine Beclere

Publications and helpful links

General Publications

• Hamzaoui O, Gouezel C, Jozwiak M, Millereux M, Sztrymf B, Prat D, Jacobs F, Monnet X, Trouiller P, Teboul JL. Increase in Central Venous Pressure During Passive Leg Raising Cannot Detect Preload Unresponsiveness. Crit Care Med. 2020 Aug;48(8):e684-e689. doi: 10.1097/CCM.0000000000004414. Erratum In: Crit Care Med. 2021 Jun 1;49(6):e662.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 23, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Shock, Cardiogenic
• Other Study ID Numbers: 2017-A03578-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No