Clinical trial NCT02108093: The Effect on Cerebral Oxygenation of Retrograde Autologous Priming of the Cardiopulmonary Bypass Circuit in Cardiac Surgery Patients
Official title: The Effect on Cerebral Oxygenation of Retrograde Autologous Priming of the Cardiopulmonary Bypass Circuit in Cardiac Surgery Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Lead sponsor: Amphia Hospital
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 220
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: prolonged intraoperative cerebral desaturation
timeFrame: Participants will be followed for the duration of the operation period, an expected average of 3 hours
Secondary outcomes:
measure: cerebral oxygenation desaturation episodes (CODE)
timeFrame: participants will be followed for the duriation of the operation period, an expected average of 3 hours
measure: Subjective Cognitive Failure Questionnaire (CFQ)
timeFrame: 3 months and 6 months after randomization
measure: blood transfusions (amount)
timeFrame: 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
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia Hospital
Study officials:
affiliation: Amphia Hospital
name: Thierry Scohy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: de Tournay-Jette 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.
citation: Murkin JM. Pathophysiological basis of CNS injury in cardiac surgical patients: detection and prevention. Perfusion. 2006 Jul;21(4):203-8. doi: 10.1191/0267659106pf869oa.
citation: 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.
citation: 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.