Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty

NCT01707953 | Completed Phase 3 DMC

• 2 other identifiers: RH-4074-OJ12012-002572-13
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this study is to examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip arthroplasty.

Conditions

Postoperative Orthostatic Hypotension; Postoperative Orthostatic Intolerance

Outcome Measures

Primary Outcomes (1)

• Orthostatic hypotension

  Orthostatic hypotension (OH) during early mobilization 6 hours after end of surgery. OH is classified according to international consensus.

  6 hours after surgery

Secondary Outcomes (3)

• Orthostatic hypotension 24 hours after surgery

  24 hours after end of surgery.

• Orthostatic Intolerance

  6 and 24 hours after end of surgery

• Treatment side effects

  6 and 24 hours after end of surgery

Other Outcomes (2)

• Haemodynamic response to mobilization 6 and 24 hours after surgery

  6 and 24 hours after end of surgery

• Heart rate variability

  before surgery, 6- and 24 hours after surgery

Study Arms (2)

Midodrine

EXPERIMENTAL

Midodrine Hydrochloride (5mg) administered as capsule 5 and 23 hours after end of surgery.

Drug: Midodrine

Placebo

PLACEBO COMPARATOR

Placebo administered as capsule 5- and 23 hours after end of surgery.

Drug: Placebo

Interventions

Midodrine DRUG

Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery).

Also known as: Gutron

Midodrine

Placebo DRUG

Placebo capsule to mimic midodrine

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for primary unilateral hip arthroplasty
• Age \>= 18 years
• Able to give informed consent

You may not qualify if:

• General anaesthesia for the current procedure
• Digoxin treatment.
• history of renal or hepatic failure
• history of glaucoma
• history chronic urinary retention requiring treatment
• history of orthostatic intolerance / hypotension
• other autonomous nervous system disease
• alcohol or drug abuse
• current malignant disease
• females in the fertile age (possible pregnancy or breast feeding)
• Treatment with anticoagulants
• BMI \> 40 kg/m2
• Dementia or cognitive dysfunction (investigators evaluation)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (3)

Gentofte Hospital, Department of orthopaedic surgery

Hellerup, 2900, Denmark

Location

Hvidovre Hospital, Department of orthopaedic surgery

Hvidovre, 2650, Denmark

Location

Vejle Sygehus, Department of orthopedic surgery

Vejle, 7100, Denmark

Location

MeSH Terms

Interventions

Midodrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Henrik Kehlet, Proffessor

  Rigshospitalet, Section for Surgical Pathophysiology

  STUDY CHAIR

• Oeivind Jans, M.D.

  Rigshospitalet, Section for Surgical Pathophysiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Research Fellow

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 16, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 20, 2014

Record last verified: 2014-01

Locations

DK (3)