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

NCT02342236 | Completed

• 1 other identifier: 06101968-3
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Biological Markers

Outcome Measures

Primary Outcomes (1)

• 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.

  Duration of the orthopedic procedure, an expected average of 2 hours.

Secondary Outcomes (2)

• 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

Study Arms (2)

cemented

OTHER

Primary hip arthroplasty with bone cement use.

Device: cemented or cementless type of hip prothesis

cementless

OTHER

Primary hip arthroplasty without bone cement use.

Device: cemented or cementless type of hip prothesis

Interventions

cemented or cementless type of hip prothesis DEVICE

cemented; cementless

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient scheduled to primary hip arthroplasty,
• orthopedic procedure under spinal anesthesia.

You may not qualify if:

• patients younger than 18 y.o.,
• surgery under general anesthesia,
• patients who refused to participate in the study.

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Department of Anesthesiology and Intensive Therapy

Warsaw, 04-141, Poland

Location

Related Publications (6)

• 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.

  PMID: 18156878 BACKGROUND

• 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.

  PMID: 11964616 BACKGROUND

• 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.

  PMID: 21079180 BACKGROUND

• 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.

  PMID: 17395862 BACKGROUND

• 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.

  PMID: 19804476 BACKGROUND

• 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.

  PMID: 19101265 BACKGROUND

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 19, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

PL (1)