Portal Vein Pulsatility Index to Assess Fluid Intolerance

Completed

• Conditions: Venous Congestion
• Interventions: Drug: Ringer's Lactate Crystalloid Solutions

• Registration Number: NCT06440772
• Lead Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-01
• Study First Posted: 2024-06-04
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-24
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tolerant Fluid Responders	Ringer's Lactate Crystalloid Solutions	Patients who are both responsive and tolerant to fluid.

Primary Outcome Measures

Name	Time	Method
Fluid Intolerance	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.

Trial Locations

Locations (1)

"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases; 🇷🇴 Bucharest, Romania