Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery

Completed

• Conditions: Complication, Postoperative; Cardiovascular Complication

• Registration Number: NCT03010969
• Lead Sponsor: Zealand University Hospital

Brief Summary

The aim of the clinical study is:

1. to examine the association between postoperative endothelial function, indirectly measured by reactive hyperemia index, and major adverse cardiovascular events including myocardial injury and cardiac death within 30, 90 and 365 days of acute abdominal surgery.

2. to examine the association between postoperative endothelial function, indirectly measured by reactive hyperemia index, and non-cardiovascular complications including non-cardiac death within 30, 90 and 365 days of acute abdominal surgery.

3. to examine the importance of the postoperative blood glucose level and the pulmonary function for postoperative complications and death within 30, 90 and 365 days of acute abdominal surgery.

4. to examine the association between postoperative endothelial function, pulmonary function and blood glucose level

5. the qualitative part of the study will examine the postoperative subjective symptoms including acute and chronic pain, quality of recovery and functional status, depressive thoughts and post-traumatic stress disorder.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Primary Completion: 2018-11
• Study Completion: 2019-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-14
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	Within 365 days of surgery	* Cardiovascular death; * Myocardial injury within postoperative day 3 (definition: peak plasma cardiac troponin-I ≥ 45ng/L (99th percentile URL, 10% CV at 40ng/L)); * Acute coronary syndrome (unstable angina pectoris, NSTEMI, STEMI); * Congestive heart failure; * Stroke; * Nonfatal cardiac arrest; * New clinically important cardiac arrhythmia; * Coronary revascularization procedure (PCI or CABG); * Sudden unexpected death
The change in reactive hyperemia index assessed by EndoPat	The change from 4-24 hours to between day 3 and 5 after surgery
Postoperative non-cardiovascular complications	Within 365 days of surgery	Non-cardiovascular death, sepsis, pneumonia, respiratory failure, surgical complications (min. Clavien-Dindo stage 3), Any non-cardiovascular life-threatening complication (Clavien-Dindo stage 4).

Secondary Outcome Measures

Name	Time	Method
Pulmonary function	Postoperative day 1 - 7 (or until discharge)
Reactive hyperemia index assessed by EndoPat	between day 3 and 5 after surgery
Blood Glucose level	Postoperative day 1 - 7 (or until discharge)
Lengths of stay	Lengths of stay from the operation day to discharge, on average 14 days.
Lengths of stay in the intensive care unit	Lengths of stay from the operation day to discharge from hospital, on average 14 days.
Readmission	Readmissions within 1 year of discharge
Nitric oxide biomarkers	4-24 hours after surgery and between postoperative day 3-5

Trial Locations

Locations (1)

Department of Surgery, Zealand University Hospital, Koge; 🇩🇰 Køge, Denmark