MObILE study - Midodrine effect on Orthostatic IntoLErance after hip and knee replacements

A randomised placebo-controlled trial to determine the effectof oral Midodrine hydrochloride to prevent orthostatic intolerance during mobilisation following total hip and knee arthroplasty

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620001342909

Acronym

MObILE

Enrollment

170

Registered

2020-12-14

Start date

2021-01-19

Completion date

2023-12-20

Last updated

2024-04-22

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

Conditions

None listed

Brief summary

After a hip or knee joint replacement it is important to mobilise (get out of bed and move) early to recover faster, and reduce the risk of complications after surgery. Mobilisation can be hindered by orthostatic intolerance, described as the development of symptoms (dizziness, nausea, vomiting, blurred vision, feeling of heat, and fainting) when standing upright. Orthostatic intolerance has been reported to happen in up to 60% of patients after surgery. Reasons include an inability of the peripheral blood vessels to constrict (tighten) properly in response to standing. Midodrine is a drug that works by constricting the peripheral blood vessels, thereby improving blood pressure. This study aims to investigate if midodrine can reduce the occurrence of orthostatic intolerance after hip and knee joint replacements. One-hundred and seventy patients will be randomised to receive either midodrine or placebo in the early postoperative period. Orthostatic intolerance will be assessed on the day of surgery (approx 6 hours after surgery), and on the first day after surgery (approx 24 hours after surgery).

Interventions

Oral Midodrine Hydrochloride 10mg administered five times in the early postoperative period; Day of surgery; 1 tablet oral every 4 hours for 2 doses Postoperative day 1; 1 tablet oral every 4 hours for 3 doses Drug administration will be carried out by a ward nurse. Prescription records and administration records will be monitored by a researcher daily, whilst patients are in the study.

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 No maximum

Healthy volunteers

Inclusion criteria

18 yr or older Elective primary unilateral total hip or total knee arthroplasty

Exclusion criteria

Supine hypertension >180 mmHg preoperatively Chronic kidney disease (eGFR below 60 mL/min/1.73m2 for more than 3 months) Hepatic failure Glaucoma Chronic urinary retention requiring treatment Taking doxazosin Documented recurrent or chronic orthostatic intolerance Known autonomic nervous system dysfunction TIA or stroke within the last 12 months Pregnant Revision surgery Unable to walk pre-operatively Unable to speak or understand English

Outcome results