Study on Baroreceptor Function in Relation to Orthostatic Blood Pressure Regulation After Hip Surgery

NCT ID: NCT01866787

Last Updated: 2015-01-16

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

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this observational study is to evaluate the baroreceptor function in relation to surgical inflammation and orthostatic intolerance after elective hip arthroplasty.

The main hypothesis is that baroreceptor function is attenuated after surgery and related to surgical inflammation.

Detailed Description

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Orthostatic intolerance and hypotension is prevalent during early mobilization after major surgery.

This observational study aims to evaluate the baroreceptor function during using a standardized evaluation protocol before, 6- and 24 hours after elective primary unilateral hip-arthroplasty.

The study hypothesis is that baroreceptor function as expressed by the valsalva ratio is attenuated after surgery and related to surgical inflammation.

Conditions

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Hypotension, Orthostatic Total Hip Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Scheduled for unilateral hip arthroplasty
* 18 years or older
* Able to give informed consent

Exclusion Criteria

* American Society of Anesthesiologists (ASA) class 3 or higher
* Chronic arrythmia (Atrial fibrillation or other arrythmia)
* Incompensated ischaemic heart disease
* Mobilization restriction due to surgical reasons
* Medical complications during admission requiring transferral to other department
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lundbeck Foundation

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Oeivind Jans

M.D., Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Øivind Jans, M.D

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Frederiksberg Hospital, Department of orthopaedic surgery

Frederiksberg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Øivind Jans, M.D

Role: CONTACT

Facility Contacts

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Arne Borgwardt, M.D.

Role: primary

Other Identifiers

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RH-4074-OJ3

Identifier Type: -

Identifier Source: org_study_id

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