Postoperative Cognitive DysfunctionRAPNCT02108093
The Effect on Cerebral Oxygenation of Retrograde Autologous Priming of the Cardiopulmonary Bypass Circuit in Cardiac Surgery Patients
A study testing retrograde autologous priming in people with Postoperative Cognitive Dysfunction, run by Amphia Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- retrograde autologous priming
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elective combined cardiac surgical procedures
Who cannot join
- Elective single cardiac surgical procedures
- off-pump procedure
- re-operation
- emergency operation
- methylene blue administration
Trial locations and contacts
1 site in 1 country.
Dorien Kimenai, Bsc contact
Thierry Scohy, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Amphia Hospital
Breda, 4800 RK
Thierry Scohy, MD, PhD
Bas Gerritse, MD, PhD
About this study
Official title: The Effect on Cerebral Oxygenation of Retrograde Autologous Priming of the Cardiopulmonary Bypass Circuit in Cardiac Surgery Patients: a Randomized Controlled Trial
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.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- retrograde autologous priming
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrograde autologous primingProcedure or surgery
Also called RAP
Retrograde autologous priming (RAP) is a technique where, the patient's own circulating blood partially replaces the priming solution in the CPB.
| Study group | Role | What they receive |
|---|---|---|
| RAP (retrograde autologous priming) group | Experimental | 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. Receives: Procedure: retrograde autologous priming |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for the duration of the operation period, an expected average of 3 hours
Secondary outcomes (3)
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%
Measured: participants will be followed for the duriation of the operation period, an expected average of 3 hours
Subjective Cognitive Failure Questionnaire (CFQ)
Three and six months after randomization the Subjective CFQ will be sent to the patients to evaluate cognition.
Measured: 3 months and 6 months after randomization
blood transfusions (amount)
The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amphia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thierry V Scohy, Amphia Hospital
- Investigators
- Thierry Scohy, MD, PhD, Principal investigator, Amphia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108093
- Sponsor's protocol ID
- RAP
- Acronym
- RAP
- Status last verified
- Dec 2014
- First submitted
- 5 Apr 2014
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19101265de 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.
PubMed 20650659Murkin JM. Pathophysiological basis of CNS injury in cardiac surgical patients: detection and prevention. Perfusion. 2006 Jul;21(4):203-8. doi: 10.1191/0267659106pf869oa.
PubMed 16939113Hwang 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.
PubMed 21576024Anastasiadis 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.
PubMed 21357641
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Cerebral Oxygenation of Retrograde Autologous Priming of the Cardiopulmonary Bypass Circuit in Cardiac Surgery Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02108093
- Acronym / sponsor ID
- RAP / RAP
- Conditions
- Postoperative Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Amphia HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAP (retrograde autologous priming) group | Experimental | Procedure: retrograde autologous primingIn 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Elective combined cardiac surgical procedures
Key exclusion criteria (5 listed)
- Elective single cardiac surgical procedures
- off-pump procedure
- re-operation
- emergency operation
- methylene blue administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrograde autologous primingAlso: RAPRetrograde autologous priming (RAP) is a technique where, the patient's own circulating blood partially replaces the priming solution in the CPB. | Procedure or surgery | RAP (retrograde autologous priming) group |
Primary outcome
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.
3 secondary outcomes
cerebral oxygenation desaturation episodes (CODE)
Time frame: participants will be followed for the duriation of the operation period, an expected average of 3 hours
Subjective Cognitive Failure Questionnaire (CFQ)
Time frame: 3 months and 6 months after randomization
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2014.
- Background: PubMed 19101265Slater 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.
- Background: PubMed 20650659de 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.
- Background: PubMed 16939113Murkin JM. Pathophysiological basis of CNS injury in cardiac surgical patients: detection and prevention. Perfusion. 2006 Jul;21(4):203-8. doi: 10.1191/0267659106pf869oa.
- Background: PubMed 21576024Hwang 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.
- Background: PubMed 21357641Anastasiadis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorien Kimenai, Bsc contact
Thierry Scohy, MD, PhD contact
Thierry Scohy, MD, PhD principal investigator
Amphia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retrograde autologous priming in people with Postoperative Cognitive Dysfunction, run by Amphia Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorien Kimenai, Bsc (dkimenai@amphia.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prolonged intraoperative cerebral desaturation (time frame: Participants will be followed for the duration of the operation period, an expected average of 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02108093, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2014.