Portal Vein Pulsatility Index to Assess Fluid Intolerance

Venous Congestion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06440772
• Other study ID #: 9593/04.04.2024
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: June 2024
• Source: Institutul de Urgenta pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
• Contact: Cosmin Balan, PhD
• Phone: +40722751501
• Email: cosmin13mara[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperemia
• Venous Congestion

Intervention

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

Locations

Country	Name	City	State
Romania	"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Institutul de Urgenta pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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