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

Postoperative Cognitive Dysfunction Clinical Trial

— RAP  

Official title:

The Effect on Cerebral Oxygenation of Retrograde Autologous Priming of the Cardiopulmonary Bypass Circuit in Cardiac Surgery Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02108093
• Other study ID #: RAP
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2014
• Last updated: December 24, 2014
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: Amphia Hospital
• Contact: Dorien Kimenai, Bsc
• Email: dkimenai[@]amphia.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Postoperative Cognitive Dysfunction

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Amphia Hospital	Breda

Sponsors (1)

Lead Sponsor	Collaborator
Amphia Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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. — View Citation

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. — View 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. — View Citation

Murkin JM. Pathophysiological basis of CNS injury in cardiac surgical patients: detection and prevention. Perfusion. 2006 Jul;21(4):203-8. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prolonged intraoperative cerebral desaturation	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.	Participants will be followed for the duration of the operation period, an expected average of 3 hours	No
Secondary	cerebral oxygenation desaturation episodes (CODE)	CODE will be defined by a reduction of 20% baseline value of rSO2 at least one minute or an absolute reduction of 50%	participants will be followed for the duriation of the operation period, an expected average of 3 hours	No
Secondary	Subjective Cognitive Failure Questionnaire (CFQ)	Three and six months after randomization the Subjective CFQ will be sent to the patients to evaluate cognition.	3 months and 6 months after randomization	No
Secondary	blood transfusions (amount)	The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital	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	No