Fluid Challenge Impact in the Portal Vein Pulsatility Depending on the Fluid Responsivness Status

Venous Congestion Clinical Trial

— FLUID-REVENGE  

Official title:

Fluid Challenge Impact in the Portal Vein Pulsatility Depending on the Fluid Responsivness Status

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05828407
• Other study ID #: 69HCL22_1115
• Secondary ID: 2023-A00196-39
• Status: Recruiting
• Start date: July 10, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: July 2023
• Source: Hospices Civils de Lyon
• Contact: Martin RUSTE, MD
• Phone: 0472118956
• Email: martin.ruste[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Portal vein pulsatility index is a marker of venous congestion evaluated by point of care ultrasound. It is associated with acute kidney injury, especially in critically ill patients. It may be considered as a dynamic marker. The investigators hypothesized that portal vein pulsatility index is higher after a fluid challenge only in patient without preload dependence in critically ill patients with cardiovascular insufficiency.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• vasopressor requirement to maintain mean arterial pressure >65mmHg AND
• at least one of the following criteria:
• arterial lactate >2mmol/L;
• capillary refill time >3s;
• mottling score >1;
• diuresis <0,5mL/h for more than 6hours.

Exclusion Criteria:

• Diameter of vena cava <20mm
• Cirrhosis
• Pregnancy
• Severe acute pulmonary edema
• Phototype 4 or 5
• Patient opposition to participate

Related Conditions & MeSH terms

• Cardiovascular Insufficiency
• Hyperemia
• Venous Congestion

Locations

Country	Name	City	State
France	Hôpital cardiologique Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Portal vein pulsatility index variation induced by the fluid challenge (%), defined by: Portal vein pulsatility index before the fluid challenge - portal vein pulsatility index after the fluid challenge.	Portal vein pulsatility index is defined as the (maximal velocity - minimal velocity) / maximal velocity assessed with doppler in portal vein estimated with point of care ultrasound.	One hour