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

NCT05828407 | Completed

• 2 other identifiers: 69HCL22_11152023-A00196-39
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Insufficiency; Venous Congestion

Keywords

Point of care ultrasound; Portal vein pulsatility index; Venous congestion; Preload dependence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cohort

Population: Critically ill patient with: * cardio circulatory insufficiency as defined by vasopressor requirement 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 * diameter of inferior vena cava \>20mm Protocol: Administration of a fluid challenge (4mL/kg of Ringer Lactate) over 5 to 10 min. Point of care ultrasound evaluation of portal vein pulsatility index and Vexus criteria before and after the fluid challenge ; fluid challenge induced cardiac index variations estimated by pulse contour analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult intensive care patients with both grade 1 or higher venous congestion (VeXus C criteria) and acute circulatory failure.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital cardiologique Louis Pradel

Bron, 69500, France

Location

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Martin RUSTE, MD

  Département d'anesthésie-réanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 25, 2023
• Study Start: July 10, 2023
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)