Perioperative Endothelial Dysfunction

Completed

• Conditions: Myocardial Injury

• Registration Number: NCT02344771
• Lead Sponsor: Zealand University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-26
• Study Start: 2015-03
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-14
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline endothelial function (reactive hyperemia index) at 4 days postoperatively	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 Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Department of Surgery, Roskilde Hospital; 🇩🇰 Roskilde, Denmark