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

Not Applicable

Completed

• Conditions: Arthroplasty, Hip Replacement; Delirium, Dementia, Amnestic, Cognitive Disorders
• Interventions: Device: cemented or cementless type of hip prothesis

• Registration Number: NCT02342236
• Lead Sponsor: Military Institute od Medicine National Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-19
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cementless	cemented or cementless type of hip prothesis	Primary hip arthroplasty without bone cement use.
cemented	cemented or cementless type of hip prothesis	Primary hip arthroplasty with bone cement use.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Therapy; 🇵🇱 Warsaw, Poland