Clinical trial NCT02342236: Cerebral Regional Oxygen Saturation and Markers of Brain Damage During Primary Hip Arthroplasty
Official title: The Regional Cerebral Oxygen Saturation and Both S100B and GFAP Proteins Serum Concentration in Patients Undergoing Primary Hip Arthroplasty.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium, Dementia, Amnestic, Cognitive Disorders
Arthroplasty, Hip Replacement
Keywords: Biological Markers
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Postoperative Cognitive Disorders (POCD) are common in hospitalized people \> 60 year old, especially in orthopedic patients. Etiology of POCD is complex, and in some aspects still remains unclear. The role of thromboembolic events in etiology of POCD was discussed. The incidence of such events in patients who underwent big joints arthroplasty can be as high as 40 to 60%, although some cases are subclinical. Thromboembolic material can block a blood flow through a vessels in the brain. As a consequence cerebral neurons can be damaged or destroyed. After neuronal damage specific substances, such as S100B protein, glial fibrillary acidic protein (GFAP) and neuron-specific enolase (NSE) are released to the blood. The serum concentrations of these biomarkers can be measured. Moreover, the block of blood flow will decrease regional cerebral saturation in affected parts of the brain.

In this project the authors would like to analyze the correlation between the regional cerebral saturation and serum concentration of both S100B protein and GFAP in orthopedic patients scheduled to primary hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* patient scheduled to primary hip arthroplasty,
* orthopedic procedure under spinal anesthesia.

Exclusion Criteria:

* patients younger than 18 y.o.,
* surgery under general anesthesia,
* patients who refused to participate in the study.

Primary outcomes:
measure: Changes in regional cerebral oxygen during primary hip arthroplasty
timeFrame: Duration of the orthopedic procedure, an expected average of 2 hours.
Secondary outcomes:
measure: Changes in serum levels of S100B protein from baseline at 72 hours after the surgery
timeFrame: 72 hours
measure: Changes in serum levels of GFAP from baseline at 72 hours after the surgery
timeFrame: 72 hours
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Anesthesiology and Intensive Therapy
Study officials:
References:
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citation: Colonna DM, Kilgus D, Brown W, Challa V, Stump DA, Moody DM. Acute brain fat embolization occurring after total hip arthroplasty in the absence of a patent foramen ovale. Anesthesiology. 2002 Apr;96(4):1027-9. doi: 10.1097/00000542-200204000-00036. No abstract available.
citation: Vos PE, Jacobs B, Andriessen TM, Lamers KJ, Borm GF, Beems T, Edwards M, Rosmalen CF, Vissers JL. GFAP and S100B are biomarkers of traumatic brain injury: an observational cohort study. Neurology. 2010 Nov 16;75(20):1786-93. doi: 10.1212/WNL.0b013e3181fd62d2.
citation: Nylen K, Csajbok LZ, Ost M, Rashid A, Blennow K, Nellgard B, Rosengren L. Serum glial fibrillary acidic protein is related to focal brain injury and outcome after aneurysmal subarachnoid hemorrhage. Stroke. 2007 May;38(5):1489-94. doi: 10.1161/STROKEAHA.106.478362. Epub 2007 Mar 29.
citation: Wiesmann M, Steinmeier E, Magerkurth O, Linn J, Gottmann D, Missler U. Outcome prediction in traumatic brain injury: comparison of neurological status, CT findings, and blood levels of S100B and GFAP. Acta Neurol Scand. 2010 Mar;121(3):178-85. doi: 10.1111/j.1600-0404.2009.01196.x. Epub 2009 Oct 5.
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.