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Fluid Responsiveness in Post-cardiac Surgery

Primary Purpose

Fluid Overload, Cardiac Surgery, Postoperative Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined end-expiratory occlusion and end-inspiratory occlusion test
Tidal volume challenge test
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fluid Overload

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients on mechanical ventilation Patients ≥18 years of age patients undergoing cardiac surgery (coronary artery bypass graft, valve repair/ replacement, combined cardiac surgery) patients with normal systolic function of the left and right ventricle patient is mechanically ventilated with a protective lung strategy Exclusion Criteria: Patients with Spontaneously breathing activity Patients undergoing emergent cardiac surgery. Patient with severe peripheral arterial occlusive disease Pregnant women Contraindication of passive leg raising test unstable post-operative course Post-operative complications such as uncontrolled bleeding, severe neurologic impairment, or accidental mechanical complications; presence of residual severe tricuspid or any valvular regurgitations low cardiac output, low ejection fractions (EF ≤45%) open chest,Pao2/Fio2 ≤ 200

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    occlusions test

    challenge test

    Arm Description

    Combined end expiratory (EEO) and inspiratory occlusion (EIO) test. A 15-s EEO separated by a time window of 1 minute to allow the hemodynamic parameters to return to baseline followed by a 15-s EIO

    Tidal volume (TV) challenge test (transient increase of TV from 6 to 8 mL/kg for 1 minute)

    Outcomes

    Primary Outcome Measures

    The number of volume responder participants could be detected using each fluid responsiveness test
    The number of volume responder participants could be detected using each fluid responsiveness test including tidal volume challenge test and combined end-expiratory occlusion and end-inspiratory occlusion test

    Secondary Outcome Measures

    Full Information

    First Posted
    July 14, 2023
    Last Updated
    July 21, 2023
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05957003
    Brief Title
    Fluid Responsiveness in Post-cardiac Surgery
    Official Title
    The Validity of Combined End-expiratory and End-inspiratory Occlusion Test and Tidal Volume Challenge Test for Prediction of Fluid Responsiveness in Immediate Post-cardiac Surgery Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    the study aims to examine the validity of combined end-expiratory and end-inspiratory occlusion test and tidal volume challenge test for prediction of fluid responsiveness in immediate post-cardiac surgery patients
    Detailed Description
    multiple studies prove that dynamic variables based on heart-lung interactions accurately can predict fluid responsiveness in mechanically ventilated patients, including pulse pressure variation (PPV) and stroke volume (SV) variation. Furthermore, passive leg raising (PLR), end-expiratory occlusion test, and tidal volume challenge test, "Mini"-fluid challenge are currently available to assess fluid responsiveness.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fluid Overload, Cardiac Surgery, Postoperative Complications

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    occlusions test
    Arm Type
    Active Comparator
    Arm Description
    Combined end expiratory (EEO) and inspiratory occlusion (EIO) test. A 15-s EEO separated by a time window of 1 minute to allow the hemodynamic parameters to return to baseline followed by a 15-s EIO
    Arm Title
    challenge test
    Arm Type
    Active Comparator
    Arm Description
    Tidal volume (TV) challenge test (transient increase of TV from 6 to 8 mL/kg for 1 minute)
    Intervention Type
    Procedure
    Intervention Name(s)
    Combined end-expiratory occlusion and end-inspiratory occlusion test
    Intervention Description
    The EEO test will be performed by interrupting the mechanical ventilation at end-expiration over 15 seconds using the end-expiratory hold button available on the ventilator. The EIO test will be performed by interrupting the mechanical ventilation at end-inspiration over 15 seconds using the end-inspiratory hold button available on the ventilator.
    Intervention Type
    Procedure
    Intervention Name(s)
    Tidal volume challenge test
    Intervention Description
    elevating tidal volume from 6 ml/kg to 8 ml/kg for only 60 seconds
    Primary Outcome Measure Information:
    Title
    The number of volume responder participants could be detected using each fluid responsiveness test
    Description
    The number of volume responder participants could be detected using each fluid responsiveness test including tidal volume challenge test and combined end-expiratory occlusion and end-inspiratory occlusion test
    Time Frame
    immediate postoperative period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients on mechanical ventilation Patients ≥18 years of age patients undergoing cardiac surgery (coronary artery bypass graft, valve repair/ replacement, combined cardiac surgery) patients with normal systolic function of the left and right ventricle patient is mechanically ventilated with a protective lung strategy Exclusion Criteria: Patients with Spontaneously breathing activity Patients undergoing emergent cardiac surgery. Patient with severe peripheral arterial occlusive disease Pregnant women Contraindication of passive leg raising test unstable post-operative course Post-operative complications such as uncontrolled bleeding, severe neurologic impairment, or accidental mechanical complications; presence of residual severe tricuspid or any valvular regurgitations low cardiac output, low ejection fractions (EF ≤45%) open chest,Pao2/Fio2 ≤ 200
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    tarek A Mostafa, MD
    Email
    dr.tarek311@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    ghada el bradey, MD
    Phone
    +201003591332
    Ext
    +2
    Email
    ghadadido@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Fluid Responsiveness in Post-cardiac Surgery

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