The effect on cerebral oxygenation of retrograde autologous priming of the CPB circuit in cardiac surgery patients: a Randomized Controlled Trial

Completed

Conditions: cognition
regional cerebral oxygenation
10007593

Registration Number: NL-OMON38712

Lead Sponsor: Amphia Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 220

Inclusion Criteria

• Gender; male/ female
• Age: >= 70 year
• Elective cardiac surgical patients who underwent combined procedure
o Coronary artery bypass graft (CABG) surgery combined with valve surgery:
o CABG/ Aortic valve replacement (AVR)
o CABG/ Mitral valve replacement (MVR)
o CABG/ Mitral valve repair (MPL)
o CABG/ Tricuspid valve replacement (TVR)
o CABG/ Tricuspid valve repair (TPL)

Exclusion Criteria

• Elective cardiac surgical patients who underwent single procedure
o Coronary artery bypass graft (CABG) (conventional, E.CCO)
o Aortic valve replacement (AVR) (conventional, minimal invasive)
o Bentall
o Combined procedure (eg. MVR/AVR, AVR/Maze)
o Tricuspid valve replacement (TVR) / Tricuspid valve repair (TPL)
o MVR/MPL (conventional, minimal invasive, Port Access Surgery)
o Maze (minimal invasive, via Thoracoscopy)
o off-pump procedures
o re-operation
o Other
• Emergency operations
• Methylene blue administration

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter of this study is prolonged intraoperative cerebral<br /><br>desaturation and will be assessed by rSO2 desaturation score50. rSO2<br /><br>desaturation score50 > 3000 is associated with increased risk of cognitive<br /><br>decline (1). Formula described by Slater et al. : rSO2 score = 50% rSO2 -<br /><br>current rSO2 (%) x time (s) will be used to calculate the rSO2 score; from the<br /><br>intraoperative cerebral oximetry data (1).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>List of secondary study parameters:<br /><br>• CODE (number and duration)<br /><br>• rSO2 during CPB<br /><br>• Subjective Cognition Failure Questionnaire (one day preoperatively, 3 months<br /><br>after randomization, 6 months after randomization)<br /><br>• Hct/ Hb during CPB<br /><br>o Nadir Hb, Hct intraoperative, during postoperative ICU & hospital stay<br /><br>• Surgical re-explorations<br /><br>• Length of ICU stay<br /><br>• Length of hospital stay<br /><br>• Hours to detubation<br /><br>• Neurological events<br /><br>• Fluid balance<br /><br>• Administration of vasoactive drugs during CPB<br /><br>• sVO2 during CPB</p><br>