Study on Baroreceptor Function in Relation to Orthostatic Blood Pressure Regulation After Hip Surgery
Baroreceptor Function and Inflammation in Relation to Orthostatic Intolerance During Early Mobilization After Elective Hip Arthroplasty
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 4, 2013
CompletedFirst Posted
Study publicly available on registry
May 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 16, 2015
January 1, 2015
2.9 years
February 4, 2013
January 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in baroreceptor function from preoperatively to 6 hours after surgery
Change in baroreceptor function as expressed by change in the blood pressure valsalva ratio during a standardized assessment before and 6 hours after surgery.
6 hours after surgery
Secondary Outcomes (6)
Orthostatic response in blood pressure
Preoperative, 6 and 24 hours after surgery
Orthostatic response in heart rate variability
preoperative, 6 and 24 hours postoperative
Orthostatic intolerance
preoperative, 6 and 24 hours after surgery
Inflammatory markers
preoperative, 6 and 24 hours postoperative
Orthostatic Hypotension
Preoperative, 6 and 24 hours postoperative.
- +1 more secondary outcomes
Study Arms (1)
Study cohort
Eligibility Criteria
Patients scheduled for elective unilateral hip arthroplasty at Frederiksberg Hospital.
You may qualify if:
- Scheduled for unilateral hip arthroplasty
- years or older
- Able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Lundbeck Foundationcollaborator
Study Sites (1)
Frederiksberg Hospital, Department of orthopaedic surgery
Frederiksberg, 2000, Denmark
Biospecimen
Blood samples for Hemoglobin measurement and plasma for inflammatory markers.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Øivind Jans, M.D
Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Research Fellow
Study Record Dates
First Submitted
February 4, 2013
First Posted
May 31, 2013
Study Start
January 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 16, 2015
Record last verified: 2015-01