Perioperative Endothelial Dysfunction

Perioperative Endothelial Dysfunction in Patients Undergoing Non-cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Injury
• Intervention / Treatment: Procedure: Elective colon cancer surgery

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Department of Surgery, Roskilde Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A population of patients with colon cancer undergoing elective cancer surgery.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Principal Investigator: Sarah E Busch, MD, Department of Surgery, Koge University Hospital, Denmark

Publications and helpful links

General Publications

• Ekeloef S, Larsen MH, Schou-Pedersen AM, Lykkesfeldt J, Rosenberg J, Gogenur I. Endothelial dysfunction in the early postoperative period after major colon cancer surgery. Br J Anaesth. 2017 Feb;118(2):200-206. doi: 10.1093/bja/aew410.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: January 22, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 14, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; General Surgery; Perioperative Care
• Other Study ID Numbers: SBpoetry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No