Fluid Responsiveness in Post-cardiac Surgery

Not Applicable

Recruiting

• Conditions: Fluid Overload; Cardiac Surgery; Postoperative Complications
• Interventions: Procedure: Combined end-expiratory occlusion and end-inspiratory occlusion test; Procedure: Tidal volume challenge test

• Registration Number: NCT05957003
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-21
• Study First Posted: 2023-07-24
• Study Start: 2023-08-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Primary Completion: 2024-08
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
occlusions test	Combined end-expiratory occlusion and end-inspiratory occlusion 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
challenge test	Tidal volume challenge test	Tidal volume (TV) challenge test (transient increase of TV from 6 to 8 mL/kg for 1 minute)

Primary Outcome Measures

Name	Time	Method
The number of volume responder participants could be detected using each fluid responsiveness test	immediate postoperative period	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

Trial Locations

Locations (1)

Faculty of medicine, Tanta university; 🇪🇬 Tanta, El Gharbyia, Egypt