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

Primary Purpose

Postoperative Orthostatic Hypotension, Postoperative Orthostatic Intolerance

Status

Completed

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

Midodrine

Placebo

About this trial

This is an interventional prevention trial for Postoperative Orthostatic Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

Gentofte Hospital, Department of orthopaedic surgery
Hvidovre Hospital, Department of orthopaedic surgery
Vejle Sygehus, Department of orthopedic surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Midodrine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Orthostatic hypotension

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

Secondary Outcome Measures

Orthostatic hypotension 24 hours after surgery

Orthostatic Intolerance

Orthostatic intolerance is defined as subjective presyncopal symptoms (dizziness, nausea etc.) during mobilization after surgery

Treatment side effects

The following side effects to Midodrine are evaluated: Pruritus Headache Supine hypertension Urinary retention

Full Information

NCT ID

NCT01707953

First Posted

October 10, 2012

Last Updated

January 17, 2014

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT01707953

Brief Title

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

Official Title

Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty - a Randomized, Placebo Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Orthostatic Hypotension, Postoperative Orthostatic Intolerance

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Midodrine

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Midodrine

Other Intervention Name(s)

Gutron

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo capsule to mimic midodrine

Primary Outcome Measure Information:

Title

Orthostatic hypotension

Description

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

Time Frame

6 hours after surgery

Secondary Outcome Measure Information:

Title

Orthostatic hypotension 24 hours after surgery

Time Frame

24 hours after end of surgery.

Title

Orthostatic Intolerance

Description

Orthostatic intolerance is defined as subjective presyncopal symptoms (dizziness, nausea etc.) during mobilization after surgery

Time Frame

6 and 24 hours after end of surgery

Title

Treatment side effects

Description

The following side effects to Midodrine are evaluated: Pruritus Headache Supine hypertension Urinary retention

Time Frame

6 and 24 hours after end of surgery

Other Pre-specified Outcome Measures:

Title

Haemodynamic response to mobilization 6 and 24 hours after surgery

Description

Haemodynamic response to mobilization (supine, sitting and standing): Response in systolic and diastolic blood pressure Response in heart rate. Response in calculated haemodynamic variables (stroke volume, peripheral resistance)

Time Frame

6 and 24 hours after end of surgery

Title

Heart rate variability

Description

Heart rate variability measures including spectral analysis and LF/HF ratio at rest and during mobilization.

Time Frame

before surgery, 6- and 24 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Scheduled for primary unilateral hip arthroplasty Age >= 18 years Able to give informed consent Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henrik Kehlet, Proffessor

Organizational Affiliation

Rigshospitalet, Section for Surgical Pathophysiology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Oeivind Jans, M.D.

Organizational Affiliation

Rigshospitalet, Section for Surgical Pathophysiology

Official's Role

Study Director

Facility Information:

Facility Name

Gentofte Hospital, Department of orthopaedic surgery

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Facility Name

Hvidovre Hospital, Department of orthopaedic surgery

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Vejle Sygehus, Department of orthopedic surgery

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

12. IPD Sharing Statement

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

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