Portal Vein Pulsatility Index to Assess Fluid Intolerance

NCT06440772 | Completed DMC

• 1 other identifier: 6066/21.02.2023
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Venous Congestion

Keywords

congestion; portal vein pulsatility; ultrasound; fluid responsiveness; fluid tolerance

Outcome Measures

Primary Outcomes (1)

• Fluid Intolerance

  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.

  10 minutes after 7 ml/kg Ringer's Lactate

Study Arms (1)

Tolerant Fluid Responders

Patients who are both responsive and tolerant to fluid.

Drug: Ringer's Lactate Crystalloid Solutions

Interventions

Ringer's Lactate Crystalloid Solutions DRUG

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

Also known as: Fluid challenge

Tolerant Fluid Responders

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

Mechanically ventilated postoperative adult patients after cardiac surgery within 6 hours after intensive care unit admission.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu: lead

Study Sites (1)

"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Bucharest, 022328, Romania

Location

Related Publications (2)

• Balan C, Morosanu B, Fodoroiu A, Dobre V, Dumitrache A, Barbulescu RT, Valeanu L, Robu C, Boros C, Nica A, Wong A, Corradi F, Grintescu IM, Bubenek-Turconi SI. Decoding portal vein pulsatility: hemodynamic determinants in a post-hoc analysis of a prospective observational trial. Ann Intensive Care. 2025 Jun 14;15(1):81. doi: 10.1186/s13613-025-01498-0.

  PMID: 40515791 DERIVED

• Morosanu B, Balan C, Boros C, Dazzi F, Wong A, Corradi F, Bubenek-Turconi SI. Incidence, predictability, and outcomes of systemic venous congestion following a fluid challenge in initially fluid-tolerant preload-responders after cardiac surgery: a pilot trial. Crit Care. 2024 Oct 22;28(1):339. doi: 10.1186/s13054-024-05124-6.

  PMID: 39439007 DERIVED

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Cosmin Balan, PhD

  "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

• Serban-Ion Bubenek-Turconi, Professor

  "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 4, 2024
• Study Start: May 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

RO (1)