Efficacy of the drug midodrine for prevention of low blood pressure during early mobilization after hip surgery

• Conditions: Postoperative orthostatic hypotension during early mobilization after fast-track hip arthroplasty; MedDRA version: 14.1Level: LLTClassification code 10021100Term: Hypotension orthostaticSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.1Level: LLTClassification code 10021102Term: Hypotension orthostatic symptomaticSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.1Level: LLTClassification code 10050632Term: Postoperative hypotensionSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 14.1Level: LLTClassification code 10036433Term: Postural hypotensionSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.1Level: PTClassification code 10031127Term: Orthostatic hypotensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2012-002572-13-DK
• Lead Sponsor: Henrik Kehlet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-17
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Scheduled for primary unilateral hip arhtroplasty in one of the participating centers
-Age >= 18 years
-Able to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: To examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on:<br>-the incidence of orthostatic intolerance 6 h after surgery<br>-the incidences of orthostatic hypotension and intolerance 24 h after surgery<br>-the haemodynamic response to mobilization 6- and 24 h after surgery.<br>-Side effects (pruritus, headache, supine orthostatic hypertension, urinary retention);Primary end point(s): 50% reduction in the incidence of orthostatic hypotension during mobilization 6 h after surgery.;Timepoint(s) of evaluation of this end point: 6 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -the incidence of orthostatic intolerance 6 h after surgery<br>-the incidences of orthostatic hypotension and intolerance 24 h after surgery<br>-the haemodynamic response to mobilization 6- and 24 h after surgery.<br>-Side effects (pruritus, headache, supine orthostatic hypertension, urinary retention);Timepoint(s) of evaluation of this end point: 6 and 24 h after surgery.