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

NCT ID: NCT02342236

Last Updated: 2016-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cemented

Primary hip arthroplasty with bone cement use.

Group Type OTHER

cemented or cementless type of hip prothesis

Intervention Type DEVICE

cementless

Primary hip arthroplasty without bone cement use.

Group Type OTHER

cemented or cementless type of hip prothesis

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cemented or cementless type of hip prothesis

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Military Institute od Medicine National Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dariusz Tomaszewski

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Anesthesiology and Intensive Therapy

Warsaw, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18156878 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11964616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21079180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17395862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19804476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19101265 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06101968-3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.