Fluid Responsiveness in Post-cardiac Surgery

NCT05957003 | Completed DMC

• 1 other identifier: fluid responsiveness
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Fluid Overload; Cardiac Surgery; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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

  immediate postoperative period

Study Arms (2)

occlusions test

ACTIVE COMPARATOR

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

Procedure: Combined end-expiratory occlusion and end-inspiratory occlusion test

challenge test

ACTIVE COMPARATOR

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

Procedure: Tidal volume challenge test

Interventions

Combined end-expiratory occlusion and end-inspiratory occlusion test 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.

occlusions test

Tidal volume challenge test PROCEDURE

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

challenge test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of medicine, Tanta university

Tanta, El Gharbyia, 31111, Egypt

Location

MeSH Terms

Conditions

Edema; Postoperative Complications

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: August 10, 2023
• Primary Completion: August 20, 2025
• Study Completion: September 1, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)