Fluid Responsiveness in Post Cardiac Surgery Patients (Cardiac)

September 1, 2024 updated by: Ain Shams University

End Expiratory Occlusion Test for Evaluation of Fluid Responsiveness in Comparison to Passive Leg Raising Test in Mechanically Ventilated Post Cardiac Surgery Patients

The aim of the study is to compare end expiratory occlusion test to passive leg raising test for prediction of fluid responsiveness in post cardiac surgery mechanically ventilated patients.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Circulatory hypervolemia and hypovolemia are both associated with worse outcomes.Intravenous fluids are similar to drugs, with serious adverse effects and changeful efficacy. Fluids should be administered only if indicated. Passive leg raising test transiently increase venous return which can be used to evaluate fluid responsiveness.There is growing evidence that the End expiratory occlusion (EEO) test reliably detects fluid responsiveness. In patients under mechanical ventilation, the inspiration increases intra-thoracic pressure and decreases venous return. The expiratory hold augments the cardiac preload which, in case of preload responsiveness, leads to a significant increase of cardiac output (CO).EEO prevents any variation in intra-thoracic pressure leading to an increase in venous return, cardiac preload and stroke volume in preload-responsive patients. There're no studies comparing EEO with passive leg raising test in cardiac surgery patients. So, this is the target of the study.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age group: 21-60years old
  • Sex: eligible both sexes
  • Post cardiac surgery
  • Sedated intubated mechanically ventilated patients (Controlled ventilation with no respiratory effort)

Exclusion Criteria:

  • Patients refusal
  • Pregnancy or any medical condition that may affect the intra abdominal pressure.
  • Lower limb deep venous thrombosis Open chest conditions impaired left-ventricular ejection fraction (<45%), arrhythmias, inter-ventricular shunt, severe peripheral arterial occlusive disease and the need for intra-aortic balloon counter pulsation

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive value of EEO and passive leg raising
Time Frame: One year
Predictive value of EEO and passive leg raising to fluid responsiveness in post cardiac surgery mechanically ventilated patients Pulse pressure variation before and after passive leg raising test
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial blood pressure
Time Frame: One year
Effect of EEO and passive leg raising to fluid responsiveness on arterial blood pressure in post cardiac surgery mechanically ventilated patients
One year
Heart rate
Time Frame: One year
Effect of EEO and passive leg raising to fluid responsiveness on heart rate in post cardiac surgery mechanically ventilated patients
One year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central venous pressure
Time Frame: One year
Effect of EEO and passive leg raising to fluid responsiveness on central venous pressure in post cardiac surgery mechanically ventilated patients
One year

Collaborators and Investigators

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

Sponsor

Ain Shams University

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)

January 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 12, 2024

Study Registration Dates

First Submitted

August 3, 2024

First Submitted That Met QC Criteria

September 1, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 3, 2024

Last Update Submitted That Met QC Criteria

September 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FAMSU MD 220/2022

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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