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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
cemented or cementless type of hip prothesis
Sponsored by
Military Institute od Medicine National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Delirium, Dementia, Amnestic, Cognitive Disorders focused on measuring Biological Markers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Anesthesiology and Intensive Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

cemented

cementless

Arm Description

Primary hip arthroplasty with bone cement use.

Primary hip arthroplasty without bone cement use.

Outcomes

Primary Outcome Measures

Changes in regional cerebral oxygen during primary hip arthroplasty
The analysis of regional cerebral oxygen saturation will start just before the anesthesia and ends just after the surgery.

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2015
Last Updated
September 12, 2016
Sponsor
Military Institute od Medicine National Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02342236
Brief Title
Cerebral Regional Oxygen Saturation and Markers of Brain Damage During Primary Hip Arthroplasty
Official Title
The Regional Cerebral Oxygen Saturation and Both S100B and GFAP Proteins Serum Concentration in Patients Undergoing Primary Hip Arthroplasty.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military Institute od Medicine National Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Dementia, Amnestic, Cognitive Disorders, Arthroplasty, Hip Replacement
Keywords
Biological Markers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cemented
Arm Type
Other
Arm Description
Primary hip arthroplasty with bone cement use.
Arm Title
cementless
Arm Type
Other
Arm Description
Primary hip arthroplasty without bone cement use.
Intervention Type
Device
Intervention Name(s)
cemented or cementless type of hip prothesis
Primary Outcome Measure Information:
Title
Changes in regional cerebral oxygen during primary hip arthroplasty
Description
The analysis of regional cerebral oxygen saturation will start just before the anesthesia and ends just after the surgery.
Time Frame
Duration of the orthopedic procedure, an expected average of 2 hours.
Secondary Outcome Measure Information:
Title
Changes in serum levels of S100B protein from baseline at 72 hours after the surgery
Description
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.
Time Frame
72 hours
Title
Changes in serum levels of GFAP from baseline at 72 hours after the surgery
Description
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.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Therapy
City
Warsaw
ZIP/Postal Code
04-141
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18156878
Citation
Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
Results Reference
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PubMed Identifier
11964616
Citation
Colonna DM, Kilgus D, Brown W, Challa V, Stump DA, Moody DM. Acute brain fat embolization occurring after total hip arthroplasty in the absence of a patent foramen ovale. Anesthesiology. 2002 Apr;96(4):1027-9. doi: 10.1097/00000542-200204000-00036. No abstract available.
Results Reference
background
PubMed Identifier
21079180
Citation
Vos PE, Jacobs B, Andriessen TM, Lamers KJ, Borm GF, Beems T, Edwards M, Rosmalen CF, Vissers JL. GFAP and S100B are biomarkers of traumatic brain injury: an observational cohort study. Neurology. 2010 Nov 16;75(20):1786-93. doi: 10.1212/WNL.0b013e3181fd62d2.
Results Reference
background
PubMed Identifier
17395862
Citation
Nylen K, Csajbok LZ, Ost M, Rashid A, Blennow K, Nellgard B, Rosengren L. Serum glial fibrillary acidic protein is related to focal brain injury and outcome after aneurysmal subarachnoid hemorrhage. Stroke. 2007 May;38(5):1489-94. doi: 10.1161/STROKEAHA.106.478362. Epub 2007 Mar 29.
Results Reference
background
PubMed Identifier
19804476
Citation
Wiesmann M, Steinmeier E, Magerkurth O, Linn J, Gottmann D, Missler U. Outcome prediction in traumatic brain injury: comparison of neurological status, CT findings, and blood levels of S100B and GFAP. Acta Neurol Scand. 2010 Mar;121(3):178-85. doi: 10.1111/j.1600-0404.2009.01196.x. Epub 2009 Oct 5.
Results Reference
background
PubMed Identifier
19101265
Citation
Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.
Results Reference
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Cerebral Regional Oxygen Saturation and Markers of Brain Damage During Primary Hip Arthroplasty

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