Study on Baroreceptor Function in Relation to Orthostatic Blood Pressure Regulation After Hip Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01866787|
Recruitment Status : Unknown
Verified January 2015 by Oeivind Jans, Rigshospitalet, Denmark.
Recruitment status was: Recruiting
First Posted : May 31, 2013
Last Update Posted : January 16, 2015
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.
|Condition or disease|
|Hypotension, Orthostatic Total Hip Replacement|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Baroreceptor Function and Inflammation in Relation to Orthostatic Intolerance During Early Mobilization After Elective Hip Arthroplasty|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866787
|Contact: Øivind Jans, M.Demail@example.com|
|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|