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

January 15, 2015 updated by: Oeivind Jans, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 2000
        • Recruiting
        • Frederiksberg Hospital, Department of orthopaedic surgery
        • Contact:
        • Principal Investigator:
          • Øivind Jans, M.D.
        • Sub-Investigator:
          • Kirsten Pors, M.Sci.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for elective unilateral hip arthroplasty at Frederiksberg Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Preoperative, 6 and 24 hours after surgery
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.
preoperative, 6 and 24 hours postoperative
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).
preoperative, 6 and 24 hours after surgery
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
preoperative, 6 and 24 hours postoperative
Orthostatic Hypotension
Time Frame: Preoperative, 6 and 24 hours postoperative.
orthostatic hypotension defined according to international guidelines.
Preoperative, 6 and 24 hours postoperative.
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
On the day of surgery: preoperatively, 6- and 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Lundbeck Foundation

Investigators

  • Principal Investigator: Øivind Jans, M.D, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

May 27, 2013

First Posted (ESTIMATE)

May 31, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RH-4074-OJ3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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