ACTRN12621000943842Not yet recruitingPhase 4
Investigating the effectiveness, feasibility and safety of Prophylactic Hypotension Avoidance iN arThrOplasty using Midodrine (PHANTOM) pilot trial in Adults
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Royal Perth Hospital
- Enrollment
- 166
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (—)
- Sex
- All
Inclusion Criteria
- •Patients undergoing elective or emergency arthroplasties, including total hip replacement, hemiarthroplasty or total knee replacement.
Exclusion Criteria
- •Inability to provide informed consent
- •Hypersensitivity/ Anaphylaxis to Midodrine
- •Weight under 60kg
- •Systolic Blood pressure >160mmHg (average of 3 readings)
- •Cardiac: Supine Hypertension, Congestive Cardiac Failure (Ejection Fraction <40%), Moderate- Severe Aortic Stenosis, Mitral Stenosis, Cardiomyopathy, Global systolic dysfunction (Ejection fraction <40%). Pulmonary Hypertension (Mean Pulmonary Arterial Pressure >25mmHg
- •Vascular: Known Severe Obliterative Peripheral Vascular Disease
- •Renal: Dialysis dependent End Stage Renal Disease, eGFR< 45mls/min
- •Gastrointestinal: Known impaired Gastrointestinal absorption, Patient not likely to be able to take oral medication within the first 24 hours
- •Neurological: Unsecured cerebral aneurysm, Severe Migraine
- •Opthalmological: Narrow angle glaucoma, Proliferative Diabetic Retinopathy
- •Endocrine: Thyrotoxicosis, Phaeochromocytoma
Investigators
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