Study on Baroreceptor Function in Relation to Orthostatic Blood Pressure Regulation After Hip Surgery
Recruitment status was: Recruiting
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.
|Hypotension, Orthostatic Total Hip Replacement|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Baroreceptor Function and Inflammation in Relation to Orthostatic Intolerance During Early Mobilization After Elective Hip Arthroplasty|
- Change in baroreceptor function from preoperatively to 6 hours after surgery [ Time Frame: 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.
- Orthostatic response in blood pressure [ Time Frame: Preoperative, 6 and 24 hours after surgery ]The response in systolic and diastolic blood pressure during postural change from supine to standing
- Orthostatic response in heart rate variability [ Time Frame: preoperative, 6 and 24 hours postoperative ]Heart rate variability during supine rest, sitting and standing as assessed by Spectral analysis.
- Orthostatic intolerance [ Time Frame: preoperative, 6 and 24 hours after surgery ]Orthostatic intolerance defined as the inability to sit or stand for 3 minutes due to presyncopal symptoms (Dizziness, Nausea, Blurred vision).
- Inflammatory markers [ Time Frame: preoperative, 6 and 24 hours postoperative ]Inflammatory markers (CRP and interleukin-6) measured at 3 separate timepoint: preoperative, 6- and 24 h after surgery
- Orthostatic Hypotension [ Time Frame: Preoperative, 6 and 24 hours postoperative. ]orthostatic hypotension defined according to international guidelines.
- Baroreceptor function [ Time Frame: On the day of surgery: preoperatively, 6- and 24 hours after surgery ]baroreceptor function as expressed by change in the blood pressure valsalva ratio during a standardized assessment
Biospecimen Retention: Samples Without DNA
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01866787
|Contact: Øivind Jans, M.Dfirstname.lastname@example.org|
|Frederiksberg Hospital, Department of orthopaedic surgery||Recruiting|
|Frederiksberg, Denmark, 2000|
|Contact: Arne Borgwardt, M.D. Arne.Borgwardt@regionh.dk|
|Principal Investigator: Øivind Jans, M.D.|
|Sub-Investigator: Kirsten Pors, M.Sci.|
|Principal Investigator:||Øivind Jans, M.D||Rigshospitalet, Denmark|