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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty - a Randomized, Placebo Controlled Trial.

Brief Summary: 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.

Detailed Summary:
Sponsor: Rigshospitalet, Denmark

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: October 10, 2012
Date Started: October 2012
Date Completion:
Last Updated: January 17, 2014
Last Verified: January 2014