Perioperative Endothelial Dysfunction

Overview

More than one in 100 otherwise healthy patients undergoing non-cardiac surgery will die within 30 days post-operatively, and of these patients 45% will die from vascular causes such as myocardial infarction. The pathogenesis of perioperative myocardial infarction is complex and to date not fully elucidated. The physiological stress response associated with the surgical procedure is believed to be central in the development of perioperative cardiovascular complications. Surgery initiates systemic inflammation, hypercoagulability and increases the production of catecholamines and cortisol. These drastic systemic changes lead to a state of myocardial oxygen supply-demand mismatch, which added to acute endothelial dysfunction and ruptures of vulnerable plaques, may result in myocardial injury. The endothelium is a regulator of vascular homeostasis, vascular tone and structure and exerts anticoagulant, antiplatelet and fibrinolytic properties. Endothelial dysfunction is characterized by a decreased vascular bioavailability of nitric oxide probably due to an increased degradation of nitric oxide via its interaction with locally produced reactive oxygen species. No clinical studies have investigated whether peri- and postoperative endothelial dysfunction is associated with an increased risk of perioperative myocardial injury. Endothelial dysfunction may be a key element in the development of perioperative myocardial injury. The aim of this observational clinical study is to closely examine the endothelial function and its dynamics in the early postoperative period.

Full Title of Study: “Perioperative Endothelial Dysfunction in Patients Undergoing Non-cardiac Surgery”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2015

Interventions

  • Procedure: Elective colon cancer surgery

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline endothelial function (reactive hyperemia index) at 4 days postoperatively
    • Time Frame: baseline before operation, 4 hours postoperatively and daily assessments day 1-4 after surgery.
    • The reactive hyperemia index is assessed non-invasively by the EndoPat system.

Secondary Measures

  • Biomarkers of endothelial function: plasma arginine, plasma asymmetric dimethylarginine and plasma tetrahydrobiopterin
    • Time Frame: before surgery, 4 hours postoperatively and daily assessments on day 1-4 after surgery
  • Biomarkers of endothelial glycocalyx degradation (syndecan-1, atrial natriuretic peptide)
    • Time Frame: before surgery, 4 hours postoperatively and daily assessments on day 1-4 after surgery.
  • Plasma cardiac troponin I
    • Time Frame: before surgery and one daily assessment on day 1-4 after surgery.

Participating in This Clinical Trial

Inclusion Criteria

• Patients scheduled for elective colon cancer surgery Exclusion Criteria:

  • Not capable of giving informed consent after oral and written information – Previously included in the trial – Surgery within 7 days of the trial

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zealand University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sarah Victoria Ekeløf Busch, MD, Ph.d. student – Zealand University Hospital
  • Overall Official(s)
    • Sarah E Busch, MD, Principal Investigator, Department of Surgery, Koge University Hospital, Denmark

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