Postoperative Orthostatic HypotensionPhase 3NCT01707953
Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty
A Phase 3 study testing Midodrine in people with Postoperative Orthostatic Hypotension and Postoperative Orthostatic Intolerance, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Orthostatic Hypotension, Postoperative Orthostatic Intolerance
- What is being tested?
- Midodrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesDenmark
- Study dates
- Oct 2012to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for primary unilateral hip arthroplasty
- Age >= 18 years
- Able to give informed consent
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Gentofte Hospital, Department of orthopaedic surgery
Hellerup, 2900
Hvidovre Hospital, Department of orthopaedic surgery
Hvidovre, 2650
Vejle Sygehus, Department of orthopedic surgery
Vejle, 7100
About this study
Official title: Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty - a Randomized, Placebo Controlled Trial.
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.
- Being tested
- Midodrine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
Also called Gutron
Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery).
PlaceboDrug
Placebo capsule to mimic midodrine
| Study group | Role | What they receive |
|---|---|---|
| Midodrine | Experimental | Midodrine Hydrochloride (5mg) administered as capsule 5 and 23 hours after end of surgery. Receives: Drug: Midodrine |
| Placebo | Placebo comparator | Placebo administered as capsule 5- and 23 hours after end of surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthostatic hypotension
Orthostatic hypotension (OH) during early mobilization 6 hours after end of surgery. OH is classified according to international consensus.
Measured: 6 hours after surgery
Secondary outcomes (3)
Orthostatic hypotension 24 hours after surgery
Measured: 24 hours after end of surgery.
Orthostatic Intolerance
Orthostatic intolerance is defined as subjective presyncopal symptoms (dizziness, nausea etc.) during mobilization after surgery
Measured: 6 and 24 hours after end of surgery
Treatment side effects
The following side effects to Midodrine are evaluated:
- Pruritus
- Headache
- Supine hypertension
- Urinary retention
Measured: 6 and 24 hours after end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oeivind Jans, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Henrik Kehlet, Proffessor, Study chair, Rigshospitalet, Section for Surgical PathophysiologyOeivind Jans, M.D., Study director, Rigshospitalet, Section for Surgical Pathophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707953
- Sponsor's protocol ID
- RH-4074-OJ1
- Other IDs
- 2012-002572-13
- Status last verified
- Jan 2014
- First submitted
- 10 Oct 2012
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty - a Randomized, Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT01707953
- Acronym / sponsor ID
- RH-4074-OJ1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midodrine | Experimental | Drug: MidodrineMidodrine Hydrochloride (5mg) administered as capsule 5 and 23 hours after end of surgery. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered as capsule 5- and 23 hours after end of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for primary unilateral hip arthroplasty
- Age >= 18 years
- Able to give informed consent
Key exclusion criteria (13 listed)
- General anaesthesia for the current procedure
- Digoxin treatment.
- history of renal or hepatic failure
- history of glaucoma
- history chronic urinary retention requiring treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidodrineAlso: GutronMidodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery). | Drug | Midodrine |
| PlaceboPlacebo capsule to mimic midodrine | Drug | Placebo |
Primary outcome
Orthostatic hypotension
Time frame: 6 hours after surgery
Orthostatic hypotension (OH) during early mobilization 6 hours after end of surgery. OH is classified according to international consensus.
3 secondary outcomes
Orthostatic hypotension 24 hours after surgery
Time frame: 24 hours after end of surgery.
Orthostatic Intolerance
Time frame: 6 and 24 hours after end of surgery
Treatment side effects
Time frame: 6 and 24 hours after end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Kehlet, Proffessor study chair
Rigshospitalet, Section for Surgical Pathophysiology
Oeivind Jans, M.D. study director
Rigshospitalet, Section for Surgical Pathophysiology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Midodrine in people with Postoperative Orthostatic Hypotension and Postoperative Orthostatic Intolerance, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthostatic hypotension (time frame: 6 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2014.