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

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

Sponsors

Lead sponsor: Military Institute of Medicine, Poland

Source Military Institute of Medicine, Poland
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.

Overall Status Completed
Start Date June 2014
Completion Date December 2015
Primary Completion Date December 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in regional cerebral oxygen during primary hip arthroplasty Duration of the orthopedic procedure, an expected average of 2 hours.
Secondary Outcome
Measure Time Frame
Changes in serum levels of S100B protein from baseline at 72 hours after the surgery 72 hours
Changes in serum levels of GFAP from baseline at 72 hours after the surgery 72 hours
Enrollment 18
Condition
Intervention

Intervention type: Device

Intervention name: cemented or cementless type of hip prothesis

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility Department of Anesthesiology and Intensive Therapy
Location Countries

Poland

Verification Date

September 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Military Institute of Medicine, Poland

Investigator full name: Dariusz Tomaszewski

Investigator title: M.D., Ph.D.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: cemented

Arm group type: Other

Description: Primary hip arthroplasty with bone cement use.

Arm group label: cementless

Arm group type: Other

Description: Primary hip arthroplasty without bone cement use.

Study Design Info

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: Single (Participant)

Source: ClinicalTrials.gov