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OsteoarthrosisPhase 2/3NCT02445898

Effect of Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Hip-arthroplasty Patients

A Phase 2/3 study testing Methylprednisolone and Isotonic Sodium Chloride in people with Osteoarthrosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study evaluates the pathophysiological effects of a single dose Methylprednisolone administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the effect on orthostatic intolerance, orthostatic hypotension and heart rate variability (HRV) to evaluate the efficacy of Methylprednisolone… Read more about this study

Who is it for?
Ages 55 to 80 years
Conditions the study is for
Osteoarthrosis
What is being tested?
Methylprednisolone and Isotonic Sodium Chloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteDenmark
Study dates
Sep 2015to Jan 2017
Phase
Phase 2/3
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 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Osteoarthrosis
  • Undergoing total unilateral hip-arthroplasty surgery
  • Speak and understand Danish
  • Have given informed content

Who cannot join

  • Revision or bilateral hip-arthroplasty surgery
  • General anaesthesia
  • Allergy or intolerance towards Methylprednisolone
  • Local or systemic infection
  • Permanent systemic treatment with steroids within 30 days peroperatively
  • Insulin-dependent diabetes
Show all 15Show fewer
  • Atrial fibrillation
  • Neurological disease incl. Parkinsons
  • Daily use of hypnotics or sedatives
  • Alcohol abuse >35 units per week
  • Active treatment of ulcer within 3 months preoperatively
  • Cancer disease
  • Autoimmune disease incl. rheumatoid arthritis
  • Pregnant or breast feeding women
  • Menopause <1 year

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Copenhagen University Hospital, Bispebjerg

    Copenhagen NV, 2400

Other trials in Denmark

About this study

Official title: Effect of Preoperative Intravenous High Dose Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Patients Scheduled for Total Hip-arthroplasty

The study evaluates the pathophysiological effects of a single dose Methylprednisolone administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the effect on orthostatic intolerance, orthostatic hypotension and heart rate variability (HRV) to evaluate the efficacy of Methylprednisolone regarding blood pressure regulation and autonomic responses after THA.

Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.

The investigators hypothesize that the group receiving Methylprednisolone will be less orthostatic intolerant, experience less orthostatic hypotension and have an improved autonomic response compared to the placebo-group, early after THA.

Read the detailed description

The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects in postoperative pain, postoperative nausea and vomiting are well-documented.

Hip-arthroplasty surgery and the inflammatory stress response in general affect the potential of recovery. Early postoperative orthostatic intolerance is common in patients undergoing THA with an incidence of 40%. The mechanism is thought related to an impaired autonomic regulation caused by surgery-induced inflammation. The effect of glucocorticoids on orthostatic intolerance, orthostatic hypotension and HRV after hip-arthroplasty surgery is unknown and calls for further investigation.

The study is to be considered as exploratory. The primary analysis of the primary outcome measure is a comparison of the incidence of orthostatic intolerance from baseline to 6 hours postoperatively between the two groups.

For calculation of sample size the difference in incidence between groups (40% versus 10%) from baseline (before surgery) to 6 hours after THA-surgery, a risk of type I errors 5% and a risk of type II errors 20% (80% power) were used.

The primary analysis is carried out on all included patients (intention-to-treat) with baseline values as covariate. Secondary exploratory per-protocol analysis might be performed. Missing outcomes will be analysed using multiple imputation due to expected strong time trends.

The secondary outcomes measures; Non-invasive blood pressure, systemic vascular resistance, cardiac output, HRV, plasma-hemoglobin, C-reactive protein.

For further details please also view the European Clinical Trials Database (EudraCT) registration:

EudraCT nr.: 2015-000102-19

Conditions
Osteoarthrosis
Being tested
Methylprednisolone, Isotonic Sodium Chloride
Keywords
Glucocorticoid, Orthostatic Intolerance, Heart Rate Variability, Hip arthroplasty, total
Medical subject headings
Osteoarthritis, Orthostatic Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethylprednisoloneDrug

    Also called Solu-Medrol

    Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)

  • Isotonic Sodium ChlorideDrug

    Placebo

Study groups in NCT02445898
Study groupRoleWhat they receive
MethylprednisoloneActive comparatorPreoperative single high dose of Solu-Medrol 125 mg iv.
Receives: Drug: Methylprednisolone
Isotonic Sodium ChloridePlacebo comparatorPreoperative single dose of isotonic Sodium Chloride
Receives: Drug: Isotonic Sodium Chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in incidence of orthostatic intolerance from baseline to 6 hours after surgery

    Measured: 6 hours after surgery

Secondary outcomes (8)

  1. Difference in incidence of orthostatic intolerance from baseline to 24 hours after surgery

    Measured: 24 hours after surgery

  2. Change in non-invasive blood pressure from baseline to 24 hours after surgery

    Measured: 24 hours after surgery

  3. Change in heart rate variability from baseline to 24 hours after surgery

    Measured: 24 hours after surgery

  4. Change in stroke volume and cardiac output from baseline to 24 hours after surgery

    Measured: 24 hours after surgery

  5. Change in systemic vascular resistance from baseline to 24 hours after surgery

    Measured: 24 hours after surgery

  6. Change in pain intensity from baseline to 24 hours after surgery

    Measured: 24 hours after surgery

  7. Change in concentration of plasma-hemoglobin from baseline to 48 hours after surgery

    Measured: 48 hours after surgery

  8. Change in concentration of C-reactive protein from baseline to 48 hours after surgery

    Measured: 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

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 2/3
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02445898
Sponsor's protocol ID
HK_VL_01_2015
Other IDs
2015-000102-19, 2015
Status last verified
Jan 2017
First submitted
13 May 2015
Last updated
18 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Husted H. Fast-track hip and knee arthroplasty: clinical and organizational aspects. Acta Orthop Suppl. 2012 Oct;83(346):1-39. doi: 10.3109/17453674.2012.700593.

    PubMed 23205862

  • Kehlet H. Fast-track hip and knee arthroplasty. Lancet. 2013 May 11;381(9878):1600-2. doi: 10.1016/S0140-6736(13)61003-X. No abstract available.

    PubMed 23663938

  • Grubb BP. Neurocardiogenic syncope and related disorders of orthostatic intolerance. Circulation. 2005 Jun 7;111(22):2997-3006. doi: 10.1161/CIRCULATIONAHA.104.482018. No abstract available.

    PubMed 15939833

  • Bundgaard-Nielsen M, Jans O, Muller RG, Korshin A, Ruhnau B, Bie P, Secher NH, Kehlet H. Does goal-directed fluid therapy affect postoperative orthostatic intolerance?: A randomized trial. Anesthesiology. 2013 Oct;119(4):813-23. doi: 10.1097/ALN.0b013e31829ce4ea.

    PubMed 23756453

  • Bundgaard-Nielsen M, Jorgensen CC, Jorgensen TB, Ruhnau B, Secher NH, Kehlet H. Orthostatic intolerance and the cardiovascular response to early postoperative mobilization. Br J Anaesth. 2009 Jun;102(6):756-62. doi: 10.1093/bja/aep083. Epub 2009 Apr 27.

    PubMed 19398452

  • Jans O, Bundgaard-Nielsen M, Solgaard S, Johansson PI, Kehlet H. Orthostatic intolerance during early mobilization after fast-track hip arthroplasty. Br J Anaesth. 2012 Mar;108(3):436-43. doi: 10.1093/bja/aer403. Epub 2011 Dec 15.

    PubMed 22174345

  • Lindberg-Larsen V, Petersen PB, Jans O, Beck T, Kehlet H. Effect of pre-operative methylprednisolone on orthostatic hypotension during early mobilization after total hip arthroplasty. Acta Anaesthesiol Scand. 2018 Aug;62(7):882-892. doi: 10.1111/aas.13108. Epub 2018 Mar 24.

    PubMed 29573263

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Methylprednisolone and Isotonic Sodium Chloride in people with Osteoarthrosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site 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 4 inclusion and 15 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Difference in incidence of orthostatic intolerance from baseline to 6 hours after surgery (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?

On the ClinicalTrials.gov record for NCT02445898, which also lists 7 linked publications.

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 18 Jan 2017.

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