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

Efficacy of midodrine for the prevention of orthostatic hypotension during early mobilization after fast-track hip arthroplasty - a randomized, placebo controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-002572-13-DK
Enrollment
Unknown
Registered
2012-07-17
Start date
2012-09-17
Completion date
Unknown
Last updated
2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative orthostatic hypotension during early mobilization after fast-track hip arthroplasty MedDRA version: 14.1 Level: LLT Classification code 10021100 Term: Hypotension orthostatic System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.1 Level: LLT Classification code 10021102 Term: Hypotension orthostatic symptomatic System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.1 Level: LLT Classification code 10050632 Term: Postoperative hypotension System Organ

Interventions

Trade Name: Gutron 5 mg Product Name: Gutron Pharmaceutical Form: Tablet INN or Proposed INN: MIDODRINE HYDROCHLORIDE CAS Number: 3092-17-9 Concentration unit: mg milligram(s) Concentration type: equa

Sponsors

Henrik Kehlet
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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: -the incidence of orthostatic intolerance 6 h after surgery -the incidences of orthostatic hypotension and intolerance 24 h after surgery -the haemodynamic response to mobilization 6- and 24 h after surgery. -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

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

Countries

Denmark

Contacts

Public ContactOeivind Jans

Section of Surgical Pathophysiology

oeivind.jans@rh.regionh.dk+4535451631

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026