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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Orthostatic Hypotension; Postoperative Orthostatic Intolerance
• Intervention / Treatment: Drug: Midodrine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Gentofte Hospital, Department of orthopaedic surgery
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital, Department of orthopaedic surgery
  • Vejle, Denmark, 7100
    • Vejle Sygehus, Department of orthopedic surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Gutron
PLACEBO_COMPARATOR: Placebo; Placebo administered as capsule 5- and 23 hours after end of surgery.	Drug: Placebo; Placebo capsule to mimic midodrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orthostatic hypotension	Orthostatic hypotension (OH) during early mobilization 6 hours after end of surgery. OH is classified according to international consensus.	6 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orthostatic hypotension 24 hours after surgery		24 hours after end of surgery.
Orthostatic Intolerance	Orthostatic intolerance is defined as subjective presyncopal symptoms (dizziness, nausea etc.) during mobilization after surgery	6 and 24 hours after end of surgery
Treatment side effects	The following side effects to Midodrine are evaluated: Pruritus; Headache; Supine hypertension; Urinary retention	6 and 24 hours after end of surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemodynamic response to mobilization 6 and 24 hours after 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)	6 and 24 hours after end of surgery
Heart rate variability	Heart rate variability measures including spectral analysis and LF/HF ratio at rest and during mobilization.	before surgery, 6- and 24 hours after surgery

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Study Chair: Henrik Kehlet, Proffessor, Rigshospitalet, Section for Surgical Pathophysiology; Study Director: Oeivind Jans, M.D., Rigshospitalet, Section for Surgical Pathophysiology

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: October 10, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (ESTIMATE): October 16, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 20, 2014
• Last Update Submitted That Met QC Criteria: January 17, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Autonomic Nervous System Diseases; Primary Dysautonomias; Hypotension; Hypotension, Orthostatic; Orthostatic Intolerance; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Adrenergic alpha-1 Receptor Agonists; Midodrine
• Other Study ID Numbers: RH-4074-OJ1; 2012-002572-13 (EUDRACT_NUMBER)