Assessing fluid responsiveness in patients after cardiac surgery
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
This study is testing new ways to see if patients who have just had heart surgery and are on a ventilator need more fluids to help them recover.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El Gharbyia) |
| Trial ID | NCT05957003 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of combined end-expiratory and end-inspiratory occlusion tests along with a tidal volume challenge test to predict fluid responsiveness in patients who have just undergone cardiac surgery. It focuses on patients who are mechanically ventilated and aims to validate dynamic variables that can indicate how well these patients respond to fluid administration. The study will involve various assessments to determine the best methods for evaluating fluid needs in this critical postoperative period.
Who should consider this trial
Good fit: Ideal candidates include mechanically ventilated patients aged 18 and older who have undergone cardiac surgery with normal left and right ventricular function.
Not a fit: Patients who are spontaneously breathing, undergoing emergent surgery, or have significant postoperative complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve fluid management in postoperative cardiac surgery patients, potentially reducing complications and enhancing recovery.
How similar studies have performed: Other studies have shown promise in using dynamic variables to predict fluid responsiveness, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tanta, El Gharbyia
- Faculty of medicine, Tanta university — Tanta, El Gharbyia, Egypt (Recruiting)
Study contacts
- Study coordinator: tarek A Mostafa, MD
- Email: dr.tarek311@yahoo.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.