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

This study has been completed.
Information provided by (Responsible Party):
Oeivind Jans, Rigshospitalet, Denmark Identifier:
First received: October 10, 2012
Last updated: January 17, 2014
Last verified: January 2014
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:

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

Primary Outcome Measures:
  • Orthostatic hypotension [ Time Frame: 6 hours after surgery ]
    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. ]
  • Orthostatic Intolerance [ Time Frame: 6 and 24 hours after end of surgery ]
    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 ]

    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 ]

    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 ]
    Heart rate variability measures including spectral analysis and LF/HF ratio at rest and during mobilization.

Estimated Enrollment: 120
Study Start Date: October 2012
Study Completion Date: September 2013
Primary Completion Date: September 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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 identifier: NCT01707953

Gentofte Hospital, Department of orthopaedic surgery
Hellerup, Denmark, 2900
Hvidovre Hospital, Department of orthopaedic surgery
Hvidovre, Denmark, 2650
Vejle Sygehus, Department of orthopedic surgery
Vejle, Denmark, 7100
Sponsors and Collaborators
Rigshospitalet, Denmark
Study Chair: Henrik Kehlet, Proffessor Rigshospitalet, Section for Surgical Pathophysiology
Study Director: Oeivind Jans, M.D. Rigshospitalet, Section for Surgical Pathophysiology
  More Information

Responsible Party: Oeivind Jans, M.D, Research Fellow, Rigshospitalet, Denmark Identifier: NCT01707953     History of Changes
Other Study ID Numbers: RH-4074-OJ1
2012-002572-13 ( EudraCT Number )
Study First Received: October 10, 2012
Last Updated: January 17, 2014

Additional relevant MeSH terms:
Hypotension, Orthostatic
Orthostatic Intolerance
Vascular Diseases
Cardiovascular Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 17, 2017