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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000943842

Acronym

PHANTOM Study

Enrollment

166

Registered

2021-07-19

Start date

2021-08-01

Completion date

2022-12-31

Last updated

2021-07-26

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

Conditions

None listed

Brief 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.

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 if Blood Pressure is below 140mmHg. The allocation will be by the use of a random number generator.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

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

Outcome results