NCT03014765

Brief Summary

Study will enroll patients scheduled for hip arthroplasty. In each subject a flow-mediated dilatation capability (FMD) of the brachial artery will be measured prior to elective surgery, within 24 hours after surgery and 5-7 days after surgery. At each session the brachial artery diameter will be measured at rest, during cuff inflation and 50 seconds after cuff deflation. From above mentioned values the increase in the diameter of the artery during reactive hyperemia will be calculated. Simultaneously with the ultrasound investigations, the blood for determination of the endothelial dysfunction markers will be collected. The participants will be contacted again 3 months after the surgery and asked about the complications which may be associated with the surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

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

Study Start

First participant enrolled

January 3, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2017

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

January 4, 2017

Last Update Submit

May 2, 2018

Conditions

Endothelial DysfunctionPostoperative Complications

Keywords

endothelial dysfunctionperioperative stresscardiovascular complicationsinflammatory markers

Outcome Measures

Primary Outcomes (1)

  • rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction

    12 months

Secondary Outcomes (2)

  • levels of blood circulating markers of increased perioperative stress and systemic inflammatory response

    12 months

  • decrease in endothelial function

    12 months

Interventions

EDOPOTHER

no intervention

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled hip arthroplasty under spinal anesthesia

You may not qualify if:

  • Acute coronary syndrome or cerebrovascular syndrome in the last 6 months
  • Acute venous thrombosis in the last 6 months
  • Episode of rheumatoid arthritis in the last 3 months or permanent therapy with prednisolone \>4mg/day
  • Acute illness or hospitalization in the last month
  • Chronic kidney failure on dialysis
  • Hepatic failure
  • Active malignant disease
  • Immunosuppression after organ transplantation
  • Pregnancy
  • No informed consent after oral and written information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Orthopaedic Anaesthesia

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 9, 2017

Study Start

January 3, 2017

Primary Completion

June 16, 2017

Study Completion

December 8, 2017

Last Updated

May 8, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share