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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02342236

Enrollment

Registered

2015-01-19

Start date

2014-06-30

Completion date

2015-12-31

Last updated

2016-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Hip Replacement, Delirium, Dementia, Amnestic, Cognitive Disorders

Keywords

Biological Markers

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.

Interventions

DEVICEcemented or cementless type of hip prothesis

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Changes in regional cerebral oxygen during primary hip arthroplasty	Duration of the orthopedic procedure, an expected average of 2 hours.	The analysis of regional cerebral oxygen saturation will start just before the anesthesia and ends just after the surgery.

Secondary

Measure	Time frame	Description
Changes in serum levels of S100B protein from baseline at 72 hours after the surgery	72 hours	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.
Changes in serum levels of GFAP from baseline at 72 hours after the surgery	72 hours	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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026