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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Rigshospitalet, Denmark
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Oeivind Jans, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01866787
First received: February 4, 2013
Last updated: January 17, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Change in baroreceptor function from preoperatively to 6 hours after surgery [ Time Frame: 6 hours after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    orthostatic hypotension defined according to international guidelines.

  • Baroreceptor function [ Time Frame: On the day of surgery: preoperatively, 6- and 24 hours after surgery ] [ Designated as safety issue: No ]
    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 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866787

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

No publications provided

Responsible Party: Oeivind Jans, M.D., Research Fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01866787     History of Changes
Other Study ID Numbers: RH-4074-OJ3
Study First Received: February 4, 2013
Last Updated: January 17, 2014
Health Authority: Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Orthostatic Intolerance
Mitral Valve Prolapse
Neurocirculatory Asthenia
Vascular Diseases
Cardiovascular Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Heart Valve Prolapse
Heart Valve Diseases
Heart Diseases
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014