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OpenTrials
Completed

NCT Number: NCT05828407

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

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.

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Key information

Conditions

Cardiovascular Insufficiency Cardiovascular Diseases Hyperemia Vascular Diseases Venous Congestion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital cardiologique Louis Pradel

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    Time frame: One hour

    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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: FLUID-REVENGE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 25, 2023
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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