Not Yet RecruitingPhase 4ACTRN12621000943842

Investigating the effectiveness of Prophylactic Hypotension Avoidance iN arThrOplasty using Midodrine (PHANTOM) pilot trial

Investigating the effectiveness, feasibility and safety of Prophylactic Hypotension Avoidance iN arThrOplasty using Midodrine (PHANTOM) pilot trial in Adults

Sponsor

Royal Perth Hospital

Enrollment

166 participants

Start Date

Aug 1, 2021

Study Type

Interventional

Conditions

Hip Arthroplasty Surgery Hypotension Knee Arthroplasty

Summary

The PHANTOM trial is a randomised, placebo controlled, blinded pilot trial looking at the use of prophylactic and perioperative Midodrine, in patients undergoing elective and emergency arthroplasties. This will determine if it is safe and effective in preventing clinically significant hypotension, intraoperatively and post-operatively, within a 24hr period. Patients will be followed up for 1 month following the index surgical procedure.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria2

Patients undergoing elective or emergency arthroplasties, including total hip replacement, hemiarthroplasty or total knee replacement.
ASA 1-4

Exclusion Criteria11

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

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Interventions

Random allocation to either oral Placebo or oral 15mg Midodrine 1hour before induction of anaesthesia. Postoperatively allocated Placebo or oral 10mg Midodrine every 4 hours for the first 24 hours

Random allocation to either oral Placebo or oral 15mg Midodrine 1hour before induction of anaesthesia. Postoperatively allocated Placebo or oral 10mg Midodrine every 4 hours for the first 24 hours if Blood Pressure is below 140mmHg. The allocation will be by the use of a random number generator.