An assessment of the impact of midodrine on early mobilisation after hip replacement surgery

Phase 4

• Conditions: Orthostatic intolerance; Total hip arthroplasty; Cardiovascular - Other cardiovascular diseases; Musculoskeletal - Osteoarthritis; Surgery - Other surgery

• Registration Number: ACTRN12620001267943
• Lead Sponsor: Sir Charles Gairdner and Osborne Park Hospital Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-25
• Study Completion: 2022-02-11
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Adults, aged > 18 years old
Elective unilateral total hip arthroplasty under spinal anaesthesia
Mentally competent to provide informed own written consent in English

Exclusion Criteria

Spinal anaesthesia not planned, or refused by patient
Chronic renal impairment
Creatinine >2mg/dL or 180micmol/L
Clinical evidence of liver failure
Heart failure
NYHA class 3 or 4
Ejection fraction < 30%
Glaucoma
Revision hip arthroplasty
Hip resurfacing surgery
Significant preoperative neuromuscular condition limiting mobility
Anaemia
Preoperative haemoglobin concentration < 110g/L
Prior diagnosis of postural hypotension
Patients taking digoxin
Pregnant/Lactating Women
Thyrotoxicosis
Pheochromocytoma
Allergy to Midodrine
Chronic urinary retention
Significant neuromuscular condition limiting mobility
Co-Enrolment in another vasopressor clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ability to successfully mobilise a minimum of 5m during the first attempt on day 1 following total hip arthroplasty. The process will be as follows:<br>•Supine BP taken by a physiotherapist using an automated sphygmomanometer <br>•Patient then sits on edge of bed and does marching on the spot exercises (whilst sitting)<br>•If successful proceed to stand them up (on day 1 this is with the assistance of at least one person or a frame)<br>•Standing blood pressure taken after 1 min and 3min<br>•If standing OK then proceed to try walking<br>•The primary outcomes measure is whether they are able to complete the 5m walk, with or without assistance, on the first attempt (Yes/No)<br>•Any aids required will also be recorded – No aid/ x1 assist/ x2 assist / frame<br><br><br>[This will be measured during the 1st attempt to mobilise on the day following surgery]