Study of Ultrasonographic Cava Femoral Ratio in the Critically Ill Patient With Shock

Hemodynamic Instability Clinical Trial

— ECHO-RCF  

Official title:

Study of Ultrasonographic Cava Femoral Ratio in the Critically Ill Patient With Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02891577
• Other study ID #: P/2015/267
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2016
• Last updated: September 6, 2016
• Start date: March 2016
• Est. completion date: September 2017

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Gaël PITON, MD, PhD
• Phone: 0033381668224
• Email: gpiton[@]chu-besancon.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

This study aims to describe the ratio of the diameter of inferior vena cava to the common femoral vein measured by ultrasonography in critically ill patients with shock, and to evaluate the potential link between this ratio and the existence of intra-abdominal disease.

Description:

Among patients presenting with severe abdominal disease and shock, observations shown that the diameter of the common femoral vein was larger than the inferior vena cava. The hypothesis is that this observation could be secondary to a compression of the inferior vena cava related to an increased intra abdominal pressure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult

• Need for ICU admission

• Need for vasopressor (epinephrine or norepinephrine) to obtain a mean arterial pressure at least of 65 mmHg

Exclusion Criteria:

• Deep venous thrombosis related to inferior vena cava or common femoral veins

• Inability to measure inferior vena cava and common femoral vein diameters using ultrasonography

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Hemodynamic Instability

Intervention

Procedure:
• Ultrasonography
At the time of ICU admission, among critically ill patients with shock, the investigators will measure the diameter of the common femoral vein and that of the inferior vena cava by ultrasonography.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of the diameter of the inferior vena cava related to the common femoral vein		Up to 28 days after ICU admission	No