RAP: The Effect on Cerebral Oxygenation of Retrograde Autologous Priming of the Cardiopulmonary Bypass Circuit in Cardiac Surgery Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RAP (retrograde autologous priming) group In the RAP (retrograde autologous priming) group, the priming solution is partially replaced by the patient's own circulating blood, before initiation of CPB. After initiation of cardiopulmonary bypass the priming volume is approximately 900 ml. |
Procedure: retrograde autologous priming
Retrograde autologous priming (RAP) is a technique where, the patient's own circulating blood partially replaces the priming solution in the CPB.
Other Names:
|
| No Intervention: Control group In the control group, the priming volume of the arterial and venous line will not be replaced by patient's own blood. The priming volume of cardiopulmonary bypass is 1300 ml in the control group. |
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Elective combined cardiac surgical procedures
Exclusion Criteria:
-
Elective single cardiac surgical procedures
-
off-pump procedure
-
re-operation
-
emergency operation
-
methylene blue administration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Amphia Hospital | Breda | Netherlands | 4800 RK |
Sponsors and Collaborators
- Amphia Hospital
Investigators
- Principal Investigator: Thierry Scohy, MD, PhD, Amphia Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Anastasiadis K, Argiriadou H, Kosmidis MH, Megari K, Antonitsis P, Thomaidou E, Aretouli E, Papakonstantinou C. Neurocognitive outcome after coronary artery bypass surgery using minimal versus conventional extracorporeal circulation: a randomised controlled pilot study. Heart. 2011 Jul;97(13):1082-8. doi: 10.1136/hrt.2010.218610. Epub 2011 Feb 28.
- de Tournay-Jetté E, Dupuis G, Bherer L, Deschamps A, Cartier R, Denault A. The relationship between cerebral oxygen saturation changes and postoperative cognitive dysfunction in elderly patients after coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):95-104. doi: 10.1053/j.jvca.2010.03.019. Epub 2010 Jul 22.
- Hwang J, Huh J, Kim J, Park S, Hwang J, Nahm FS, Hahn S. The effect of retrograde autologous priming of the cardiopulmonary bypass circuit on cerebral oxygenation. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):995-9. doi: 10.1053/j.jvca.2011.02.017. Epub 2011 May 14.
- Murkin JM. Pathophysiological basis of CNS injury in cardiac surgical patients: detection and prevention. Perfusion. 2006 Jul;21(4):203-8. Review.
- Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.
- RAP