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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Oeivind Jans, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01866787
First Posted: May 31, 2013
Last Update Posted: January 16, 2015
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.
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Oeivind Jans, Rigshospitalet, Denmark
  Purpose

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
Hypotension, Orthostatic Total Hip Replacement

Study Type: Observational
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

Further study details as provided by Oeivind Jans, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Blood samples for Hemoglobin measurement and plasma for inflammatory markers.

Estimated Enrollment: 30
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)
Groups/Cohorts
Study cohort

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for elective unilateral hip arthroplasty at Frederiksberg Hospital.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Øivind Jans, M.D oeivind.jans@regionh.dk

Locations
Denmark
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.         
Sponsors and Collaborators
Rigshospitalet, Denmark
Lundbeck Foundation
Investigators
Principal Investigator: Øivind Jans, M.D Rigshospitalet, Denmark
  More Information

Responsible Party: Oeivind Jans, M.D., Research Fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01866787     History of Changes
Other Study ID Numbers: RH-4074-OJ3
First Submitted: February 4, 2013
First Posted: May 31, 2013
Last Update Posted: January 16, 2015
Last Verified: January 2015

Keywords provided by Oeivind Jans, Rigshospitalet, Denmark:
Postoperative orthostatic intolerance
Surgical inflammatory response

Additional relevant MeSH terms:
Hypotension
Orthostatic Intolerance
Hypotension, Orthostatic
Vascular Diseases
Cardiovascular Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms