Postoperative Cognitive Deficit (POCD) Clinical Trial
Official title:
Biomarker Development for Postoperative Cognitive Impairment in the Elderly (BioCog)
The research leading consortium to these results has received funding from the European Union
Seventh Framework Programme [FP7/2007-2013] under grant agreement no 602461 (www.biocog.eu).
The investigators will establish valid biomarkers panels (neuroimaging and molecular) for
risk and clinical outcome prediction of postoperative delirium (POD)/postoperative cognitive
deficit (POCD) in elective surgical patients (Age ≥ 65 years) in study centers in
Berlin,Germany (data collection within 2 years after initial hospital stay) and Utrecht, The
Netherlands (data collection within 1 year after initial hospital stay), thereof
cerebrospinal fluid (only once on day of surgery in patients with planned spinal
anesthesia/combined spinal epidural analgesia in patients, only in Berlin).
A control group of ASA II/III- patients is collected for measuring the learning experience
during the cognitive testings. The participants are matched on age, education, and gender to
the study patients. The ASA II/III- control patients receive additionally MRI-scan (3 Tesla)
at baseline, after 3 months and after 1 (Utrecht) and 2 years (Berlin).
To analyze scanner variability we additionally measure at maximum 20 subjects (Age ≥ 65
years, ASA I and II) from Utrecht in the MRI scanner (3-Tesla) in Berlin and vice versa.
A study group at maximum (n= 80) and is collected for measuring 7 Tesla MRI at two timepoints
(Baseline and 90 days).The primary endponit of this substudy is gamma amino-butyric acid
concentration in CNS after 3-months (measured by MRI). A retrospective comparison group
(extracting 8000 intensive care unit patient data from the patient data management system
during the BioCog study period in 2016) to analyse economic effects that are caused by the
implementation of quality indicators in health care.
An interim-analysis is performed on the primary endpoint after 400 included patients.
The resulting (multivariate) expert system is expected: 1) to support clinical
decision-making in patient care, e.g. to balance the individual POD/POCD risk against the
expected overall clinical outcome of an (elective) surgical intervention, 2) to allow the
design of more sophisticated and hypothesis-driven clinical studies and drug trials
(translational research) in the future. The latter will be possible on the basis of
biomarker-based sub-grouping of patients and a better understanding of relevant
pathophysiological processes.
Furthermore, a state-of-the art clinical database and biobank will be created that does not
yet exist worldwide. Both the expert system and the reference database/biobank will expand
the leadership of the contributing academic institutions in this particular research area. In
addition, the newly created biobank will become an integral part of the European Biobanking
and Biomolecular Resources Research Infrastructure (BBMRI) which allows top address specific
and hypothesis-driven research questions.
Most notably, the developed (multivariate) expert system also has the potential for
commercialization. Possible customers are: 1) physicians and hospital departments being
involved in pre-surgical decision making, 2) pharmaceutical industry intending to conduct
biomarker-based drug trials in POD/POCD.
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