ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 7 for:    19101265 [PUBMED-IDS]
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):
Thierry V Scohy, Amphia Hospital

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
Postoperative Cognitive Dysfunction Procedure: retrograde autologous priming Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

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 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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%

  2. 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.

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Dorien Kimenai, Bsc dkimenai@amphia.nl
Contact: Thierry Scohy, MD, PhD tscohy@amphia.nl

Locations
Netherlands
Amphia Hospital Recruiting
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         
Sponsors and Collaborators
Amphia Hospital
Investigators
Principal Investigator: Thierry Scohy, MD, PhD Amphia Hospital

Publications:
Responsible Party: Thierry V Scohy, MD, PhD, Amphia Hospital
ClinicalTrials.gov Identifier: NCT02108093     History of Changes
Other Study ID Numbers: RAP
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders