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Completed

NCT Number: NCT06440772

Portal Vein Pulsatility Index to Assess Fluid Intolerance

This study uses the portal vein pulsatility index (PVPI) to assess fluid intolerance amongst fluid responders.

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Key information

Conditions

Venous Congestion Cardiovascular Diseases Hyperemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Bucharest, 022328, Romania

About this study

This prospective observational study aims to use the portal vein pulsatility index (PVPI) to assess fluid intolerance in fluid responders. The investigators will enroll mechanically ventilated postoperative adult patients within 6 hours of ICU admission after cardiac surgery. Patients will undergo a Passive Leg Raising (PLR) test and Left Ventricular Outflow Tract (LVOT) recording using transthoracic echocardiography. The main objective is to predict fluid intolerance after a fluid challenge of 7 ml/kg Ringer Lactate over 10 minutes in initially tolerant fluid responders.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent.
  • Mechanically ventilated patients within 6 hours after ICU admission following surgery who are considered for fluid administration to optimize haemodynamics.
  • Sinus rhythm.

Exclusion criteria

  • A condition known to interfere with portal vein flow assessment or interpretation (liver cirrhosis or chronic hepatic disease, suprahepatic or portal vein thrombosis).
  • Any mechanical circulatory support.
  • Cardiac transplant.
  • Poor transthoracic echocardiographic window.

Treatment and study plan

Ringer's Lactate Crystalloid Solutions

Drug

7 ml/kg ml of Ringer's Lactate is given in 10 min amongst initially tolerant fluid responders.

Other names: Fluid challenge

Primary outcomes

  1. Fluid Intolerance

    Time frame: 10 minutes after 7 ml/kg Ringer's Lactate

    A portal vein pulsatility index greater than 50%, calculated as (Vmax - Vmin) / Vmax, with no upper limit and 0% as the minimum limit. Higher values indicate worse outcomes. Ultrasonographic portal spectral waveform was used to measure Vmax and Vmin.

Sponsors and collaborators

Lead sponsor

Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Other

Registry information

Official study title

Assessing Fluid Intolerance Using Portal Vein Pulsatility Index Post-Passive Leg Raising Test in Fluid Responders: A Prospective Cohort Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2024
Registry last updated
Aug 27, 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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