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

NCT03753672 | Unknown

• 1 other identifier: 2017-A03578-45
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Shock

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

preload responsive

defined as an increase in Velocity time integral of the sub-aortic flow greater or equal to 10%

Diagnostic Test: preload responsiveness

preload unresponsive

defined as an increase in Velocity time integral of the sub-aortic flow lower than 10%

Diagnostic Test: preload responsiveness

Interventions

preload responsiveness DIAGNOSTIC_TEST

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 responsive; preload unresponsive

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• patients\<18 years old
• pregnancy
• instaility justifying rapid increase in cathecolamines

Sponsors & Collaborators

• Hopital Antoine Beclere: lead

Study Sites (1)

Hamzaoui Olfa

Clamart, 92141, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 32697509 DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 27, 2018
• Study Start: December 10, 2017
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

FR (1)