The Effect on Cerebral Oxygenation of Retrograde Autologous Priming of the Cardiopulmonary Bypass Circuit in Cardiac Surgery Patients (RAP)
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|ClinicalTrials.gov Identifier: NCT02108093|
Recruitment Status : Unknown
Verified December 2014 by Thierry V Scohy, Amphia Hospital.
Recruitment status was: Recruiting
First Posted : April 9, 2014
Last Update Posted : December 25, 2014
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|
|Postoperative Cognitive Dysfunction||Procedure: retrograde autologous priming||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
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 Name: RAP
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.
- prolonged intraoperative cerebral desaturation [ Time Frame: 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.
- cerebral oxygenation desaturation episodes (CODE) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108093
|Breda, Netherlands, 4800 RK|
|Principal Investigator: Thierry Scohy, MD, PhD|
|Sub-Investigator: Bas Gerritse, MD, PhD|
|Sub-Investigator: Nardo van der Meer, MD, PhD|
|Sub-Investigator: Dorien Kimenai, Bsc|
|Principal Investigator:||Thierry Scohy, MD, PhD||Amphia Hospital|