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

Total Hip Replacement Clinical Trial

Official title:

Baroreceptor Function and Inflammation in Relation to Orthostatic Intolerance During Early Mobilization After Elective Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01866787
• Other study ID #: RH-4074-OJ3
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2013
• Last updated: January 15, 2015
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: Rigshospitalet, Denmark
• Contact: Øivind Jans, M.D
• Email: oeivind.jans[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Intolerance
• Total Hip Replacement

Locations

Country	Name	City	State
Denmark	Frederiksberg Hospital, Department of orthopaedic surgery	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Orthostatic response in blood pressure	The response in systolic and diastolic blood pressure during postural change from supine to standing	Preoperative, 6 and 24 hours after surgery	No
Secondary	Orthostatic response in heart rate variability	Heart rate variability during supine rest, sitting and standing as assessed by Spectral analysis.	preoperative, 6 and 24 hours postoperative	No
Secondary	Orthostatic intolerance	Orthostatic intolerance defined as the inability to sit or stand for 3 minutes due to presyncopal symptoms (Dizziness, Nausea, Blurred vision).	preoperative, 6 and 24 hours after surgery	No
Secondary	Inflammatory markers	Inflammatory markers (CRP and interleukin-6) measured at 3 separate timepoint: preoperative, 6- and 24 h after surgery	preoperative, 6 and 24 hours postoperative	No
Secondary	Orthostatic Hypotension	orthostatic hypotension defined according to international guidelines.	Preoperative, 6 and 24 hours postoperative.	No
Secondary	Baroreceptor function	baroreceptor function as expressed by change in the blood pressure valsalva ratio during a standardized assessment	On the day of surgery: preoperatively, 6- and 24 hours after surgery	No