Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery. The POETRY Abdominal Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Complication
- Sponsor
- Zealand University Hospital
- Enrollment
- 224
- Locations
- 1
- Primary Endpoint
- Major adverse cardiovascular events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The aim of the clinical study is:
- 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.
- 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.
- 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.
- to examine the association between postoperative endothelial function, pulmonary function and blood glucose level
- 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.
Investigators
Sarah Victoria Ekeløf Busch
MD
Zealand University Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Major adverse cardiovascular events
Time Frame: 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
Time Frame: The change from 4-24 hours to between day 3 and 5 after surgery
Postoperative non-cardiovascular complications
Time Frame: 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 Outcomes
- 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)