NCT02445898

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

May 13, 2015

Last Update Submit

January 17, 2017

Conditions

Osteoarthrosis

Keywords

GlucocorticoidOrthostatic IntoleranceHeart Rate VariabilityHip arthroplasty, total

Outcome Measures

Primary Outcomes (1)

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

    6 hours after surgery

Secondary Outcomes (8)

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

    24 hours after surgery

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

    24 hours after surgery

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

    24 hours after surgery

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

    24 hours after surgery

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

    24 hours after surgery

  • +3 more secondary outcomes

Study Arms (2)

Methylprednisolone

ACTIVE COMPARATOR

Preoperative single high dose of Solu-Medrol 125 mg iv.

Drug: Methylprednisolone

Isotonic Sodium Chloride

PLACEBO COMPARATOR

Preoperative single dose of isotonic Sodium Chloride

Drug: Isotonic Sodium Chloride

Interventions

MethylprednisoloneDRUG

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

Also known as: Solu-Medrol
Methylprednisolone
Isotonic Sodium ChlorideDRUG

Placebo

Isotonic Sodium Chloride

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital, Bispebjerg

Copenhagen NV, 2400, Denmark

Location

Related Publications (7)

  • 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.

    PMID: 23205862BACKGROUND

  • 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.

    PMID: 23663938BACKGROUND

  • 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.

    PMID: 15939833BACKGROUND

  • 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.

    PMID: 23756453BACKGROUND

  • 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.

    PMID: 19398452BACKGROUND

  • 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.

    PMID: 22174345RESULT

  • 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.

    PMID: 29573263DERIVED

MeSH Terms

Conditions

OsteoarthritisOrthostatic Intolerance

Interventions

MethylprednisoloneMethylprednisolone HemisuccinateSodium Chloride

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Viktoria Lindberg-Larsen, MD

    Section for Surgical Pathophysiology, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 15, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

DK(1)