The Effect on Cerebral Oxygenation of Retrograde Autologous Priming of the Cardiopulmonary Bypass Circuit in Cardiac Surgery Patients

Not Applicable

• Conditions: Postoperative Cognitive Dysfunction

• Registration Number: NCT02108093
• Lead Sponsor: Amphia Hospital

Brief Summary

The effect of retrograde autologous priming (RAP) on regional cerebral oxygenation (rSO2) still remains unclear, because studies are limited in sample size and study design, and because of the absence of prospective studies. The investigators hypothesize that RAP limits the degree of hemodilution and thereby limits prolonged intraoperative cerebral desaturation during cardiopulmonary bypass (CPB), compared to the conventional priming method.

The primary objective of this study is to determine whether RAP limits the degree of hemodilution and limits prolonged intraoperative cerebral desaturation during cardiopulmonary bypass, compared to the conventional priming method. Prolonged intraoperative cerebral desaturation will be assessed by rSO2 desaturation score50. rSO2 desaturation score50 \> 3000 is associated with increased risk of cognitive decline. The investigators hypothesize that RAP limits the degree of hemodilution and thereby limits the incidence of rSO2 desaturation score50 \> 3000 with a relative difference of 50%.

The subjects who are divided in the RAP group, the retrograde autologous priming technique will be used, where the patient's own circulating blood partially will be replaced by the priming solution in the cardiopulmonary bypass. In the Control group the conventional priming method will be used. The main study parameters is rSO2 desaturation score50.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-05
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-09
• Status Verified: 2014-12
• Study Start: 2014-12
• Last Update Submitted: 2014-12-24
• Last Update Posted: 2014-12-25
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Elective combined cardiac surgical procedures

Exclusion Criteria

• Elective single cardiac surgical procedures
• off-pump procedure
• re-operation
• emergency operation
• methylene blue administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
prolonged intraoperative cerebral desaturation	Participants will be followed for the duration of the operation period, an expected average of 3 hours	The primary study parameter of this study is prolonged intraoperative cerebral desaturation and will be assessed by rSO2 desaturation score50. rSO2 desaturation score50 \> 3000 is associated with increased risk of cognitive decline. Formula described by Slater et al. : rSO2 score = 50% rSO2 - current rSO2 (%) x time (s) will be used to calculate the rSO2 score; from the intraoperative cerebral oximetry data.

Secondary Outcome Measures

Name	Time	Method
cerebral oxygenation desaturation episodes (CODE)	participants will be followed for the duriation of the operation period, an expected average of 3 hours	CODE will be defined by a reduction of 20% baseline value of rSO2 at least one minute or an absolute reduction of 50%
Subjective Cognitive Failure Questionnaire (CFQ)	3 months and 6 months after randomization	Three and six months after randomization the Subjective CFQ will be sent to the patients to evaluate cognition.
blood transfusions (amount)	participants will be followed for the duration of ICU stay, an expected average of 2 days/ And participants will be followed for the duration of hospital stay, an expected average of 3 weeks	The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital

Trial Locations

Locations (1)

Amphia Hospital; 🇳🇱 Breda, Netherlands