Clinical trial NCT02344771: Perioperative Endothelial Dysfunction
Official title: Perioperative Endothelial Dysfunction in Patients Undergoing Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Injury
Keywords: Endothelial dysfunction
General Surgery
Perioperative Care
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A population of patients with colon cancer undergoing elective cancer surgery.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline endothelial function (reactive hyperemia index) at 4 days postoperatively
timeFrame: baseline before operation, 4 hours postoperatively and daily assessments day 1-4 after surgery.
Secondary outcomes:
measure: Biomarkers of endothelial function: plasma arginine, plasma asymmetric dimethylarginine and plasma tetrahydrobiopterin
timeFrame: before surgery, 4 hours postoperatively and daily assessments on day 1-4 after surgery
measure: Biomarkers of endothelial glycocalyx degradation (syndecan-1, atrial natriuretic peptide)
timeFrame: before surgery, 4 hours postoperatively and daily assessments on day 1-4 after surgery.
measure: Plasma cardiac troponin I
timeFrame: before surgery and one daily assessment on day 1-4 after surgery.
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Department of Surgery, Roskilde Hospital
Study officials:
affiliation: Department of Surgery, Koge University Hospital, Denmark
name: Sarah E Busch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.