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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01866787

Enrollment

Registered

2013-05-31

Start date

2013-01-31

Completion date

2015-12-31

Last updated

2015-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Orthostatic, Total Hip Replacement

Keywords

Postoperative orthostatic intolerance, Surgical inflammatory response

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in baroreceptor function from preoperatively to 6 hours after surgery	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.

Secondary

Measure	Time frame	Description
Orthostatic response in heart rate variability	preoperative, 6 and 24 hours postoperative	Heart rate variability during supine rest, sitting and standing as assessed by Spectral analysis.
Orthostatic intolerance	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).
Orthostatic response in blood pressure	Preoperative, 6 and 24 hours after surgery	The response in systolic and diastolic blood pressure during postural change from supine to standing
Orthostatic Hypotension	Preoperative, 6 and 24 hours postoperative.	orthostatic hypotension defined according to international guidelines.
Baroreceptor function	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
Inflammatory markers	preoperative, 6 and 24 hours postoperative	Inflammatory markers (CRP and interleukin-6) measured at 3 separate timepoint: preoperative, 6- and 24 h after surgery

Countries

Denmark

Contacts

Primary ContactØivind Jans, M.D

oeivind.jans@regionh.dk

Outcome results