NCT03759574

Brief Summary

Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing unilateral THA

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 28, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 18, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

November 28, 2018

Last Update Submit

January 27, 2020

Conditions

Orthostatic IntoleranceOrthostatic HypotensionPostoperative Complications

Keywords

Orthostatic IntoleranceOrthostatic Hypotension

Outcome Measures

Primary Outcomes (2)

  • Incidence of orthostatic intolerance

    Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization

    6 hours postoperatively

  • Incidence of orthostatic hypotension

    Orthostatic hypotension is defined as a fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg during mobilization

    6 hours postoperatively

Secondary Outcomes (17)

  • Changes in systolic arterial pressure (SAP) during mobilization

    Preoperatively, 6 and 24 hours postoperatively

  • Changes in diastolic arterial pressure (DAP) during mobilization

    Preoperatively, 6 and 24 hours postoperatively

  • Changes in mean arterial pressure (MAP) during mobilization

    Preoperatively, 6 and 24 hours postoperatively

  • Changes in systemic vascular resistance (SVR) during mobilization

    Preoperatively, 6 and 24 hours postoperatively

  • Changes in cardiac output (CO) during mobilization

    Preoperatively, 6 and 24 hours postoperatively

  • +12 more secondary outcomes

Other Outcomes (4)

  • Pain score

    Preoperatively, 6 and 24 hours postoperatively

  • Estimated bleeding

    Intraoperatively, 6 and 24 hours postoperatively

  • Opioid use

    6 and 24 hours postoperatively

  • +1 more other outcomes

Study Arms (2)

Orthostatic intolerant (OI)

Patients that experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg) during mobilisation

Orthostatic tolerant (OT)

Patients that do not experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg) during mobilisation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing primary unilateral total hip arthroplasty in spinal anesthesia in standardized fast-track setting

You may qualify if:

  • Age 18-65
  • Written informed consent
  • Patients that speak and understand Danish
  • Patients undergoing primary unilateral total hip arthroplasty in spinal anesthesia in standardized fast-track setting

You may not qualify if:

  • Alcohol and drug abuse
  • Cognitive dysfunction
  • History of orthostatic hypotension
  • Use of anxiolytic or antipsychotic drugs
  • Use of opioids
  • Use of following vasodilator antihypertensive drugs: beta-blockers, angiotensin converting enzyme inhibitors (ACEI), angiotensin 2 receptor blockers (ARBs), calcium channel blockers
  • Use of loop diuretics, thiazid diuretics and potassium-sparing diuretics
  • Use of Gabapentin
  • Arrhythmias or heart failure
  • Diabetes mellitus type I
  • Diabetes mellitus type II
  • History of following diseases in the autonomic nervous system: Parkinson disease, multiple sclerosis, autonomic neuropathies
  • History of cerebral apoplexy or transitory cerebral ischemia
  • Dementia
  • American Society of Anesthesiologists (ASA) score ≥ 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Hospital

Copenhagen, Denmark

RECRUITING

Related Publications (5)

  • 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: 22174345BACKGROUND

  • 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: 29573263BACKGROUND

  • Jans O, Mehlsen J, Kjaersgaard-Andersen P, Husted H, Solgaard S, Josiassen J, Lunn TH, Kehlet H. Oral Midodrine Hydrochloride for Prevention of Orthostatic Hypotension during Early Mobilization after Hip Arthroplasty: A Randomized, Double-blind, Placebo-controlled Trial. Anesthesiology. 2015 Dec;123(6):1292-300. doi: 10.1097/ALN.0000000000000890.

    PMID: 26492477BACKGROUND

  • 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

  • Jans O, Kehlet H. Postoperative orthostatic intolerance: a common perioperative problem with few available solutions. Can J Anaesth. 2017 Jan;64(1):10-15. doi: 10.1007/s12630-016-0734-7. Epub 2016 Sep 14. No abstract available.

    PMID: 27638295BACKGROUND

MeSH Terms

Conditions

Orthostatic IntoleranceHypotension, OrthostaticPostoperative Complications

Condition Hierarchy (Ancestors)

Primary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHypotensionVascular DiseasesCardiovascular DiseasesPathologic Processes

Central Study Contacts

Ana-Marija Hristovska, MD

CONTACT

+4538621508ana-marija.hristovska.02@regionh.dk

Nicolai Foss, MD

CONTACT

nicolai.bang.foss@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicial Investigator, Medical Doctor, PhD-student

Study Record Dates

First Submitted

November 28, 2018

First Posted

November 30, 2018

Study Start

March 18, 2019

Primary Completion

January 1, 2021

Study Completion

May 15, 2021

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)