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

Rigshospitalet

Status and phase: Completed; Phase 3

Conditions: Postoperative Orthostatic Intolerance; Postoperative Orthostatic Hypotension

Treatments: Drug: Midodrine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01707953

2012-002572-13 (EudraCT Number)

RH-4074-OJ1

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Midodrine

Experimental group

Description:

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

Treatment:

Drug: Midodrine

Placebo

Placebo Comparator group

Description:

Placebo administered as capsule 5- and 23 hours after end of surgery.

Treatment:

Drug: Placebo