Perioperative Endothelial Dysfunction

NCT ID: NCT02344771

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Myocardial Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Elective colon cancer surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sarah Victoria Ekeløf Busch

MD, Ph.d. student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah E Busch, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Koge University Hospital, Denmark

Locations

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Department of Surgery, Roskilde Hospital

Roskilde, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 28100523 (View on PubMed)

Other Identifiers

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SBpoetry

Identifier Type: -

Identifier Source: org_study_id

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