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Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty

This study is currently recruiting participants.
Verified November 2012 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Oeivind Jans, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01707953
First received: October 10, 2012
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

The aim of this study is to examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip arthroplasty.


Condition Intervention Phase
Postoperative Orthostatic Hypotension
Postoperative Orthostatic Intolerance
 Drug: Midodrine
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty - a Randomized, Placebo Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Orthostatic hypotension [ Time Frame: 6 hours after surgery ] [ Designated as safety issue: No ]
    Orthostatic hypotension (OH) during early mobilization 6 hours after end of surgery. OH is classified according to international consensus.


Secondary Outcome Measures:
  • Orthostatic hypotension 24 hours after surgery [ Time Frame: 24 hours after end of surgery. ] [ Designated as safety issue: No ]
  • Orthostatic Intolerance [ Time Frame: 6 and 24 hours after end of surgery ] [ Designated as safety issue: No ]
    Orthostatic intolerance is defined as subjective presyncopal symptoms (dizziness, nausea etc.) during mobilization after surgery

  • Treatment side effects [ Time Frame: 6 and 24 hours after end of surgery ] [ Designated as safety issue: Yes ]

    The following side effects to Midodrine are evaluated:

    • Pruritus
    • Headache
    • Supine hypertension
    • Urinary retention


Other Outcome Measures:
  • Haemodynamic response to mobilization 6 and 24 hours after surgery [ Time Frame: 6 and 24 hours after end of surgery ] [ Designated as safety issue: No ]

    Haemodynamic response to mobilization (supine, sitting and standing):

    • Response in systolic and diastolic blood pressure
    • Response in heart rate.
    • Response in calculated haemodynamic variables (stroke volume, peripheral resistance)

  • Heart rate variability [ Time Frame: before surgery, 6- and 24 hours after surgery ] [ Designated as safety issue: No ]
    Heart rate variability measures including spectral analysis and LF/HF ratio at rest and during mobilization.


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Midodrine
Midodrine Hydrochloride (5mg) administered as capsule 5 and 23 hours after end of surgery.
 Drug: Midodrine
Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery).
Other Name: Gutron
Placebo Comparator: Placebo
Placebo administered as capsule 5- and 23 hours after end of surgery.
 Drug: Placebo
Placebo capsule to mimic midodrine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for primary unilateral hip arthroplasty
  • Age >= 18 years
  • Able to give informed consent

Exclusion Criteria:

  • General anaesthesia for the current procedure
  • Digoxin treatment.
  • history of renal or hepatic failure
  • history of glaucoma
  • history chronic urinary retention requiring treatment
  • history of orthostatic intolerance / hypotension
  • other autonomous nervous system disease
  • alcohol or drug abuse
  • current malignant disease
  • females in the fertile age (possible pregnancy or breast feeding)
  • Treatment with anticoagulants
  • BMI > 40 kg/m2
  • Dementia or cognitive dysfunction (investigators evaluation)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707953

Contacts
Contact: Oeivind Jans, M.D. +4535451631 oeivind.jans@rh.regionh.dk

Locations
Denmark
Gentofte Hospital, Department of orthopaedic surgery Recruiting
Hellerup, Denmark, 2900
Contact: Søren Solgaard         ssol0005@geh.regionh.dk    
Principal Investigator: Søren Solgaard            
Hvidovre Hospital, Department of orthopaedic surgery Not yet recruiting
Hvidovre, Denmark, 2650
Contact: Henrik Husted         henrik.husted@hvh.regionh.dk    
Principal Investigator: Henrik Husted            
Vejle Sygehus, Department of orthopedic surgery Recruiting
Vejle, Denmark, 7100
Contact: Per Kjærsgaard-Andersen         pka@dadlnet.dk    
Principal Investigator: Per Kjærsgaard-Andersen            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Henrik Kehlet, Proffessor Rigshospitalet, Section for Surgical Pathophysiology
Study Director: Oeivind Jans, M.D. Rigshospitalet, Section for Surgical Pathophysiology
  More Information

No publications provided

Responsible Party: Oeivind Jans, M.D, Research Fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01707953     History of Changes
Other Study ID Numbers: RH-4074-OJ1, 2012-002572-13
Study First Received: October 10, 2012
Last Updated: November 12, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Hypotension, Orthostatic
Hypotension
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
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on May 22, 2013