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Completed

NCT Number: NCT02342236

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Intensive Therapy

Warsaw, 04-141, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cemented or cementless type of hip prothesis

Device

Primary outcomes

  1. Changes in regional cerebral oxygen during primary hip arthroplasty

    Time frame: 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 outcomes

  1. Changes in serum levels of S100B protein from baseline at 72 hours after the surgery

    Time frame: 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.

  2. Changes in serum levels of GFAP from baseline at 72 hours after the surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Military Institute od Medicine National Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 19, 2015
Registry last updated
Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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