Cerebral Regional Oxygen Saturation and Markers of Brain Damage During Primary Hip Arthroplasty

Delirium, Dementia, Amnestic, Cognitive Disorders Clinical Trial

Official title:

The Regional Cerebral Oxygen Saturation and Both S100B and GFAP Proteins Serum Concentration in Patients Undergoing Primary Hip Arthroplasty.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342236
• Other study ID #: 06101968-3
• Status: Completed
• Phase: N/A
• First received: January 5, 2015
• Last updated: September 12, 2016
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: Military Institute of Medicine, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arthroplasty, Hip Replacement
• Cognition Disorders
• Delirium
• Delirium, Dementia, Amnestic, Cognitive Disorders
• Dementia
• Neurocognitive Disorders

Intervention

Device:
• cemented or cementless type of hip prothesis

Locations

Country	Name	City	State
Poland	Department of Anesthesiology and Intensive Therapy	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (6)

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. — View Citation

Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. — View Citation

Nylén K, Csajbok LZ, Ost M, Rashid A, Blennow K, Nellgård 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. Epub 2007 Mar 29. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in regional cerebral oxygen during primary hip arthroplasty	The analysis of regional cerebral oxygen saturation will start just before the anesthesia and ends just after the surgery.	Duration of the orthopedic procedure, an expected average of 2 hours.	No
Secondary	Changes in serum levels of S100B protein from baseline at 72 hours after the surgery	The serum concentration of S100B protein will be measured [1] just before the surgery, [2] just after the end of the surgery, an expected average of two hours, [3] 6 hours after the beginning of the surgery, [4] 24 hours after the beginning of the surgery, and [5] 72 hours after the beginning of the surgery.	72 hours	No
Secondary	Changes in serum levels of GFAP from baseline at 72 hours after the surgery	The serum concentration of GFAP protein will be measured [1] just before the surgery, [2] just after the end of the surgery, an expected average of two hours, [3] 6 hours after the beginning of the surgery, [4] 24 hours after the beginning of the surgery, and [5] 72 hours after the beginning of the surgery.	72 hours	No