Completed

NCT Number: NCT01707953

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

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.

Completed

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Key information

Conditions

Postoperative Orthostatic Hypotension Postoperative Orthostatic Intolerance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gentofte Hospital, Department of orthopaedic surgery, Hellerup, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Midodrine

Drug

Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery).

Other names: Gutron

Placebo

Drug

Placebo capsule to mimic midodrine

Primary outcomes

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 outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Oct 16, 2012
Registry last updated: Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.