Perioperative Inflammatory Response Assessment in High-risk Patients Undergoing Noncardiac Surgery
- Conditions
- InflammationCardiovascular ComplicationPostoperative ComplicationsMyocardial Ischemia
- Interventions
- Diagnostic Test: Laboratory measurements
- Registration Number
- NCT04753307
- Lead Sponsor
- Medical University of Vienna
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1400
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients at least 45 years at-risk for cardiovascular complications Laboratory measurements -
- Primary Outcome Measures
Name Time Method Composite of cardiovascular complications within 30 days after surgery and one year after surgery The primary aim of the study is to investigate the influence of the maximum C-reactive protein value (over the first 3 days after surgery) on the incidence of major cardiovascular complications within 30 days after surgery. The composite binary endpoint is defined as myocardial infarction, myocardial injury after noncardiac surgery, new onset of atrial fibrillation, stroke or death.
- Secondary Outcome Measures
Name Time Method Acute Kidney Injury - Procalcitonin within 5 days after surgery We will evaluate the influence of Procalcitonin on the occurrence of postoperative acute kidney injury.
Interleukin 6 within 30 days after surgery We investigate the influence of the Interleukin 6 ,measured within the first five days after surgery, on the incidence of cardiovascular complications within 30 days after surgery (combined binary endpoint).
Acute Kidney Injury - C-reactive proteint within 5 days after surgery We will evaluate the influence C-reactive protein on the occurrence of postoperative acute kidney injury.
C-reactive protein within 30 days after surgery Secondary goals of the study are to investigate the influence of the C-reactive protein on day 5 on the incidence of cardiovascular complications within 30 days after surgery (combined binary endpoint).
Acute Kidney Injury - Interleukin 6 within 5 days after surgery We will evaluate the influence of Interleukin 6 on the occurrence of postoperative acute kidney injury.
Procalcitonin within 30 days after surgery We investigate the influence of the procalcitonin ,measured within the first five days after surgery, on the incidence of cardiovascular complications within 30 days after surgery (combined binary endpoint).
Acute Kidney Injury - Copeptin within 5 days after surgery We will evaluate the influence of Copeptin on the occurrence of postoperative acute kidney injury.
Days at home within 30 days (DAH 30) within 30 days after surgery We will evaluate the correlation between perioperative inflammation (C-reactive protein, Interleukin 6, Procalcitonin, Copeptin) and the number of days patient spend at home after surgery within 30 days (DAH30). Outcomes measure: Hospital discharge data will be used to calculate hospital length of stay. DAH30 will be calculated using mortality and hospitalization data from the date of the index surgery (day 0).
For example, if a patient will die on day 2 after surgery, they were assigned 0 DAH30. If a patient will be discharged from hospital at day 6 after surgery but will be readmitted for 4 days before the second hospital discharge, we will assign 20 DAH30. If a patient will die within 30 days after surgery, irrespective of whether they will spend time at home, DAH30 will be scored as 0.NT-proBNP within 5 days after surgery We will evaluate the correlation of each of the following inflammatory parameters including C-reactive protein, Interleukin 6, Procalcitonin, Copeptin on postoperative NT-proBNP concentration. NT-proBNP will be measured before surgery, and on the first, second and third postoperative day.
Copeptin within 30 days after surgery We investigate the influence of the copeptin ,measured within the first five days after surgery, on the incidence of cardiovascular complications within 30 days after surgery (combined binary endpoint).
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria