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Trial record 3 of 7 for:    19101265 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02342236
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Dariusz Tomaszewski, 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.


Condition or disease Intervention/treatment Phase
Delirium, Dementia, Amnestic, Cognitive Disorders Arthroplasty, Hip Replacement Device: cemented or cementless type of hip prothesis Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Regional Cerebral Oxygen Saturation and Both S100B and GFAP Proteins Serum Concentration in Patients Undergoing Primary Hip Arthroplasty.
Study Start Date : June 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
cemented
Primary hip arthroplasty with bone cement use.
Device: cemented or cementless type of hip prothesis
cementless
Primary hip arthroplasty without bone cement use.
Device: cemented or cementless type of hip prothesis



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342236


Locations
Poland
Department of Anesthesiology and Intensive Therapy
Warsaw, Poland, 04-141
Sponsors and Collaborators
Military Institute of Medicine, Poland

Publications:

Responsible Party: Dariusz Tomaszewski, M.D., Ph.D., Military Institute of Medicine, Poland
ClinicalTrials.gov Identifier: NCT02342236     History of Changes
Other Study ID Numbers: 06101968-3
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016

Keywords provided by Dariusz Tomaszewski, Military Institute of Medicine, Poland:
Biological Markers

Additional relevant MeSH terms:
Dementia
Delirium
Cognition Disorders
Neurocognitive Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms