Postoperative Cognitive Dysfunction
Conditions
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.
Interventions
PROCEDUREretrograde autologous priming
Retrograde autologous priming (RAP) is a technique where, the patient's own circulating blood partially replaces the priming solution in the CPB.
Sponsors
Amphia Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective combined cardiac surgical procedures
Exclusion criteria
* Elective single cardiac surgical procedures * off-pump procedure * re-operation * emergency operation * methylene blue administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Netherlands
Contacts
Primary ContactDorien Kimenai, Bsc
Backup ContactThierry Scohy, MD, PhD
Outcome results
None listed