Effects of different modes of cardiopulmonary bypass in patients undergoing cardiac surgery

Not Applicable

• Conditions: Effects of pulsatile cardiopulmonary bypass (CPB) in patients undergoing cardiac surgery with median sternotomy; Surgery

• Registration Number: ISRCTN11243508
• Lead Sponsor: Slovenian Research and Innovation Agency

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-21
• Last Update Posted: 3 June 2024
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB)
2. Expected aortic cross-clamp (ACC) time of >45 minutes
3. Full or partial median sternotomy with central cannulation (mini-CPB should not be used)
4. surgery starting in the morning:
4.1. Cardiac valve surgery
4.2. Isolated coronary artery bypass grafting (CABG)
4.3. Combination of valvular and CABG surgery
4.4. Any of the above combined with ascending aorta surgery
(NO concomitant radio-frequency ablations, NO concomitant carotid artery surgery)

Exclusion Criteria

1. Refusal to participate in the study
2. Pregnant women
3. Patients with previous cardiac surgery (i.e., redo surgery)
4. Patients with left ventricular ejection fraction <30%
5. Patients on chemo/immunosuppressive therapy (including inhaled corticosteroids, antileukocyte drugs or TNF-a blockers)
6. Patients with body mass index, >35 kg·m-2 or <18 kg·m-2
7. Patients with a body surface area (BSA - duBois formula) >2.20 m2 (as it would be impossible to achieve pulsatile pump flow equivalent to a cardiac index of 2.0-2.4, without exceeding maximum safe line pressure in the extracorporeal circuit)
8. Patients with any autoimmune diseases, immunocompromised patients (e.g., with AIDS) or with leucopoenia (<3.5·109 cells·L-1)
9. Clinical and/or laboratory signs of infection
10. Patients with advanced chronic lung disease with pO2 on air: <9.8 kPa
11. Patients with known liver disease (albumin <30 g/L; bilirubin >34.2µmol·L-1)
12. Patients with renal failure (serum creatinine >176 µmol·L-1)
13. Patients with malignant diseases within the last 5 years (i.e., remission or cure 5 years or longer)
14. Patients with ischemic stroke or myocardial infarction (STEMI) within the last 3 months
15. Patients with known epilepsy
16. Patients with known allergy to any drugs used in the study protocol

Exclusion criteria - after enrolment:
Two analyses will be performed, one based on the treatment received and the second one with the additional exclusion criteria which could have an additional effect on the measured outcomes of endothelial dysfunction, inflammation, and/or oxidative stress; for example, patients who received systemic glucocorticoid medication before the last blood sampling.

Study & Design

• Study Type: Interventional
• Study Design: Not specified