Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving ACEIs and ARBs

NCT04842058 | Unknown DMC

• 1 other identifier: H-20017723
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Incidence and pathophysiologic hemodynamics of postoperative orthostatic intolerance and orthostatic hypotension in patients receiving antihypertensives

Conditions

Orthostatic Intolerance; Orthostatic Hypotension

Keywords

Orthostatic Hypotension; Orthostatic Intolerance; Postoperative period; Antihypertensives; Autonomic dysfunction

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 (31)

• 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

Other Outcomes (9)

• Pain score during mobilisation

  Preoperatively, 6 and 24 hours postoperatively

• Estimated intraoperative bleeding

  During surgery

• Intraoperative fluid balance

  Intraoperative

Study Arms (2)

Orthostatic tolerant patients (OT)

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

Other: Mobilisation procedure

Orthostatic intolerant patients (OI)

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

Other: Mobilisation procedure

Interventions

Mobilisation procedure OTHER

A standardized mobilization procedure was performed preoperatively \~ 1h before surgery and was repeated 6h and 24h after surgery. The mobilization procedure included patient supine rest (5 minutes), followed by 45° passive leg raise (PLR) (3 minutes), supine rest (5 minutes), sitting on the edge of the bed with feet resting on the floor (3 minutes) followed by standing using a walker while the patient was encouraged verbally to stand on toes and shift body weight from one leg to the other (3 minutes) and finally rest in supine position (5 minutes). The procedure was terminated prematurely in any position if patients experienced unbearable symptoms of OI or upon a decrease of systolic arterial pressure (SAP) \> 30 mmHg.

Orthostatic intolerant patients (OI); Orthostatic tolerant patients (OT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving antuhypertensives (ACEIs, ARBs) and undergoing primary unilateral total hip arthroplasty in spinal anesthesia in standardized fast-track setting

You may qualify if:

• Patients undergoing primary unilateral total hip arthroplasty (THA) in spinal anaesthesia in standardized fast-track setting
• Habitual use of angiontensin-Converting Enzyme Inhibitors (ACEIs) and/or angiotensin 2 receptor blockers (ARBs) on any indication
• Patients \> 18
• Patients that understand and speak Danish
• Patients that have provided written informed consent

You may not qualify if:

• Alcohol abuse
• Any type of substance abuse
• Chronic pain treated by habitual use of opioids
• Habitual use of anxiolytic, antidepressant and/or antipsychotic drugs
• History of cerebral apoplexy or transitory cerebral ischemia
• History of previous orthostatic intolerance or hypotension
• History of diabetes mellitus
• History of following diseases of the autonomic nervous system: Parkinson disease, multiple sclerosis, multiple system atrophy, autonomic neuropathies
• Cognitive dysfunction
• Dementia
• American Society of Anesthesiologists (ASA) \> 3

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Kehlet, Henrik, M.D., Ph.D.: collaborator

Study Sites (1)

Hvidovre University Hospital

Copenhagen, 2960, Denmark

RECRUITING

Related Publications (2)

• 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: 22174345 BACKGROUND

• 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: 27638295 BACKGROUND

MeSH Terms

Conditions

Orthostatic Intolerance; Hypotension, Orthostatic; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 12, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)