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Fluid Responsiveness in Post-cardiac Surgery

T

Tanta University

Status

Completed

Conditions

Postoperative Complications
Cardiac Surgery
Fluid Overload

Treatments

Procedure: Combined end-expiratory occlusion and end-inspiratory occlusion test
Procedure: Tidal volume challenge test

Study type

Interventional

Funder types

Other

Identifiers

NCT05957003
fluid responsiveness

Details and patient eligibility

About

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

Full 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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups

occlusions test
Active Comparator group
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
Treatment:
Procedure: Combined end-expiratory occlusion and end-inspiratory occlusion test
challenge test
Active Comparator group
Description:
Tidal volume (TV) challenge test (transient increase of TV from 6 to 8 mL/kg for 1 minute)
Treatment:
Procedure: Tidal volume challenge test

Trial contacts and locations

1

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Central trial contact

tarek el bradey, MD; tarek A Mostafa, MD

Data sourced from clinicaltrials.gov

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