Perioperative Inflammatory Response Assessment in High-risk Patients Undergoing Noncardiac Surgery

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

UNKNOWN

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-19

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Complications Cardiovascular Complication Myocardial Ischemia Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients at least 45 years at-risk for cardiovascular complications

Laboratory measurements

Intervention Type DIAGNOSTIC_TEST

Inflammatory and cardiac biomarkers will be measured before surgery, and on the first, second, third and fifth postoperative day

Interventions

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Laboratory measurements

Inflammatory and cardiac biomarkers will be measured before surgery, and on the first, second, third and fifth postoperative day

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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)

* 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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No