Clinical trial NCT04753307: Perioperative Inflammatory Response Assessment in High-risk Patients Undergoing Noncardiac Surgery
Official title: Perioperative Inflammatory Response Assessment in High-risk Patients Undergoing Noncardiac Surgery - a Prospective Non-interventional Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complications
Cardiovascular Complication
Myocardial Ischemia
Inflammation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
First posted: 2021-02-15
Enrollment: 1400
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at least 45 years and at-risk to develop postoperative cardiovascular complications undergoing noncardiac surgery.

Brief summary: Postoperative cardiovascular complications are common after noncardiac surgery. The association between perioperative inflammation and the occurrence of cardiovascular complications after surgery is still unknown. Therefore, we will evaluate as our primary aim the association between patients with increased postoperative inflammation, assessed with C-reactive protein measurements, and the occurrence of major cardiovascular complications after noncardiac surgery. We will further evaluate the influence of perioperative inflammation on the occurrence of postoperative acute kidney injury. We will also evaluate the association between inflammation and the influence on Days-At-Home within 30 days. Furthermore, we will evaluate the association between increased inflammatory biomarkers and postoperative N-terminal pro brain natriuretic peptide (NT-proBNP) concentration.


Eligibility criteria: All patients need to meet all of the following criteria for inclusion (1-4):

1. Surgery planned for more than two hours
2. ≥ 45 years of age
3. Provide written informed consent AND
4. Fulfill ≥ 1 of the following criteria (A-K)

Inclusion Criteria:

* NT-proBNP ≥ 200 ng/L
* Troponin T \> 25 ng/L
* History of coronary artery disease
* History of peripheral artery disease (PAD)
* 75 years or older
* History of transient ischemic attack (TIA) or stroke
* Current smoking or cessation of smoking within 2 years
* Diabetes or currently taking anti-diabetic drug
* Hyperlipidemia
* History of hypertension or currently taking an antihypertensive drug
* Atrial fibrillation

Exclusion Criteria:

* Patients on immune-suppressive therapy
* ICU patients undergoing surgery
* Preoperative Sepsis/systemic inflammatory syndrome (SIRS) needing ICU treatment
* Preoperative hemodynamically instable patients, who require vasopressor or inotropic support
* History of severe heart failure (defined as left ventricular ejection fraction (LVEF) \< 30%)
* Liver cirrhosis
* Chronic inflammatory bowel diseases (CIBD)
* Severe rheumatic diseases requiring immunosuppressive treatment

Primary outcomes:
measure: Composite of cardiovascular complications
timeFrame: within 30 days after surgery and one year after surgery
Secondary outcomes:
measure: C-reactive protein
timeFrame: within 30 days after surgery
measure: Acute Kidney Injury - C-reactive proteint
timeFrame: within 5 days after surgery
measure: Acute Kidney Injury - Interleukin 6
timeFrame: within 5 days after surgery
measure: Acute Kidney Injury - Procalcitonin
timeFrame: within 5 days after surgery
measure: Acute Kidney Injury - Copeptin
timeFrame: within 5 days after surgery
measure: Days at home within 30 days (DAH 30)
timeFrame: within 30 days after surgery
measure: NT-proBNP
timeFrame: within 5 days after surgery
measure: Interleukin 6
timeFrame: within 30 days after surgery
measure: Copeptin
timeFrame: within 30 days after surgery
measure: Procalcitonin
timeFrame: within 30 days after surgery
Other outcomes:
measure: Atrial fibrillation (AF) evaluation
timeFrame: within 5 days after surgery
measure: SARS-Cov-2 - Inflammation
timeFrame: within first 5 days after surgery
measure: SARS-Cov-2 - Cardiovascular Complications
timeFrame: One year after surgery
measure: SARS-Cov-2 One Year Follow-Up
timeFrame: One year after surgery
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
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citation: Ridker PM, MacFadyen JG, Everett BM, Libby P, Thuren T, Glynn RJ; CANTOS Trial Group. Relationship of C-reactive protein reduction to cardiovascular event reduction following treatment with canakinumab: a secondary analysis from the CANTOS randomised controlled trial. Lancet. 2018 Jan 27;391(10118):319-328. doi: 10.1016/S0140-6736(17)32814-3. Epub 2017 Nov 13.