Fluid Responsiveness Tests in Critically Ill Patients During Admission to the Intensive Care Unit

December 28, 2024 updated by: Ryszard Gawda, Uniwersytecki Szpital Kliniczny w Opolu

Possibility of Applying Fluid Responsiveness Tests in Critically Ill Patients During Admission to the Intensive Care Unit - a Prospective Observational Study.

The goal of this observational study is to investigate the prevalence of conditions allowing the performance fluid responsiveness tests in critically ill patients during admission to the intensive care unit.

Study Overview

Status

Completed

Detailed Description

Patients admitted to the intensive care unit are very often hemodynamically unstable. In these cases fluid responsiveness tests should be performed to assess whether the patient would benefit from the fluid administration.

However, fluid responsiveness tests have many limitations including lack of spontaneous breathing, necessity of invasive mechanical ventilation with tidal volume of > 8 mL/kg ideal body weight, regular hearth rhythm, and lack of abdominal hypertension.

In the study, the investigators evaluated the prevalence of conditions enabling the performance fluid responsiveness tests in patients admitted to the intensive care unit. An assessment was performed within the six hours after admission to the intensive care unit. Evaluation was based on transthoracic echocardiography, clinical examination of the patients, and data derived from anamnesis.

The following fluid responsiveness tests were included into assessment: passive leg raising test, end-expiratory occlusion test, pulse pressure variation, stroke volume variation, velocity time integral variation in left ventricle output track, tidal volume challenge, inferior vena cava diameter variation, and superior vena cava diameter variation.

The aim of the study was to assess how many patients have the conditions allowing performance fluid responsiveness tests during admission to the intensive care unit.

Study Type

Observational

Enrollment (Actual)

389

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

      • Opole, Poland, 45-401
        • Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

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

Probability Sample

Study Population

Adult patients admitted to the intensive care unit

Description

Inclusion Criteria:

1. Adult patients admitted to the intensive care unit

Exclusion Criteria:

  1. Age under 18
  2. The researcher unavailable in the intensive care unit
  3. Patient assessment cannot be completed within the first six hours after admission to the ICU

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
Patients treated in the intensive care unit
Patients treated in the intensive care unit during the first six hours after admission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the prevalence of conditions allowing the performance fluid responsiveness tests during admission to the intensive care unit.
Time Frame: Six hours after admission to the intensive care unit
The primary aim of the study is to assess the prevalence of conditions allowing the performance fluid responsiveness tests during admission to the intensive care unit.
Six hours after admission to the intensive care unit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess which fluid responsiveness test based on heart-lung interactions can be applied most often during admission to the intensive care unit
Time Frame: Six hours after admission to the intensive care unit
The secondary aim of the study is to assess which fluid responsiveness test based on heart-lung interaction can be applied most often during admission to the intensive care unit
Six hours after admission to the intensive care unit
To assess the percentage of patients in shock whom fluid responsiveness tests can be performed during admission to the intensive care unit
Time Frame: Six hours from the admission to the intensive care unit.
Secondary aim include an assessment the percentage of patients in shock whom fluid responsiveness tests can be performed during admission to the intensive care unit.
Six hours from the admission to the intensive care unit.

Collaborators and Investigators

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

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)

April 3, 2023

Primary Completion (Actual)

May 27, 2024

Study Completion (Actual)

May 27, 2024

Study Registration Dates

First Submitted

December 7, 2024

First Submitted That Met QC Criteria

December 7, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PossFluRespTests

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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