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

Phase 4

• Conditions: Surgery; Hypotension; Hip Arthroplasty; Knee Arthroplasty; Cardiovascular - Other cardiovascular diseases; Surgery - Other surgery

• Registration Number: ACTRN12621000943842
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-19
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of Midodrine - Highest absolute Blood Pressure values in PACU, after study drug dosage measured in mmHg via sphygmomanometer[Measured every 2 hours for up to 24hrs postoperatively];Feasibility of trial measured by annualised recruitment rate as assessed via study records and event rate at the conclusion of the trial.[Annualised recruitment rate];Safety- Rate of intervention for hypertension as assessed via patient medical records;[72 hours post-operatively,]