Fluid Responsiveness in Post-cardiac Surgery

NCT ID: NCT05957003

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2025-09-01

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.

Conditions

Fluid Overload; Cardiac Surgery; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

occlusions test

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

Group Type: ACTIVE_COMPARATOR

Combined end-expiratory occlusion and end-inspiratory occlusion test

Intervention Type: PROCEDURE

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.

challenge test

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

Group Type: ACTIVE_COMPARATOR

Tidal volume challenge test

Intervention Type: PROCEDURE

elevating tidal volume from 6 ml/kg to 8 ml/kg for only 60 seconds

Interventions

Combined end-expiratory occlusion and end-inspiratory occlusion test

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

Tidal volume challenge test

elevating tidal volume from 6 ml/kg to 8 ml/kg for only 60 seconds

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

tarek abdel hay mostafa

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine, Tanta university

Tanta, El Gharbyia, Egypt

Countries

Egypt

Other Identifiers

fluid responsiveness

Identifier Type: -

Identifier Source: org_study_id