Biomarkers to guide perioperative management and improve outcome in high-risk surgery

Recruiting

• Conditions: Adverse event; complication; 10007593

• Registration Number: NL-OMON54308
• Lead Sponsor: Amphia Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 4819

Inclusion Criteria

- Cardiac surgery (isolated coronary artery bypass grafting or combined with
single valve surgery, isolated single valve surgery)
- Gastrointestinal surgery (colorectal, pancreatic, gastric surgery,
hyperthermic intraperitoneal chemotherapy).
- Vascular surgery (open and endovascular aortic surgery, peripheral vascular
surgery)
- Lung surgery (pneumonectomy,(bi)(sleeve)lobectomy or segmentectomy)

Exclusion Criteria

- Age < 18 years - Pregnancy - Emergent surgery - No informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters are levels of PCT, CRPhs, IL-6, GDF-15, sFLT, NT-proBNP,<br /><br>cTNThs, CysC and NGAL.<br /><br><br /><br>The primary outcome parameter is a major postoperative complication (within 30<br /><br>days of surgery) and includes surgical site infection, pneumonia, sepsis, acute<br /><br>kidney injury, major adverse cardiac events and all-cause mortality</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are levels of Hb, Ht, MCV, RDW, reticulocytes,<br /><br>thrombocytes, leucocytes, MPV, urea, creatinine, sodium, potassium, chloride,<br /><br>calcium, phosphate, magnesium, ASAT, ALAT, LDH, ALP, gamma GT, bilirubin, CK,<br /><br>albumin, glucose, Cholesterol, Triglycerides, HDL-cholesterol, LDL-cholesterol,<br /><br>serum iron, ferritin, transferrin saturation. vitamin D, TSH, FT4, igf-1, SHBG.<br /><br><br /><br>Secondary study endpoints are:<br /><br>Duration of ICU stay<br /><br>ICU readmission<br /><br>ICU mortality<br /><br>Failure to rescue<br /><br>Duration of hospital stay<br /><br>Hospital readmission<br /><br>Hospital mortality<br /><br>30-day mortality<br /><br>120-day mortality<br /><br>1-year mortality<br /><br>2-year mortality<br /><br>Days alive and out of the hospital at 120 days<br /><br>Myocardial injury<br /><br>Change in disability (measured with the World Health Organization Disability<br /><br>Assessment Schedule (WHODAS 2.0, 12-item version)</p><br>