Portal Vein Pulsatility Index to Assess Fluid Intolerance

August 24, 2024 updated by: Balan Ion Cosmin, Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 022328
        • "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tolerant Fluid Responders
Patients who are both responsive and tolerant to fluid.
Drug: Ringer's Lactate Crystalloid Solutions
7 ml/kg ml of Ringer's Lactate is given in 10 min amongst initially tolerant fluid responders.
Other Names:
  • Fluid challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes after 7 ml/kg Ringer's Lactate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Cosmin Balan, PhD, "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
  • Study Chair: Serban-Ion Bubenek-Turconi, Professor, "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 1, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 24, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6066/21.02.2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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