Biomarkers to Guide Perioperative Management and Improve Outcome in High-risk Surgery

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Objective: To describe the perioperative biomarker response in surgical patients with and without a postoperative complication and construct a preoperative and postoperative prediction model for postoperative complications. To systematically collect perioperative blood samples and clinical data in high-risk surgical patients for the development en analysis of biomarkers. Study design: Multicenter, prospective, observational study. Study population: 4819 patients undergoing elective cardiac, colorectal, vascular and lung surgery. Intervention (if applicable): Not applicable. Main study parameters/endpoints: Main study parameters are levels of PCT, CRPhs, IL-6, GDF-15, sFLT, NT-proBNP, cTNThs, CysC and NGAL. Main study endpoint is the occurrence of a major postoperative complication which is defined as a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death within 30 days of surgery. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In each patient five blood samples will be drawn for analysis. Most of the blood samples are drawn simultaneously with routine perioperative laboratory testing, which is common in this study population. In case a patient is admitted to the Intensive Care Unit blood samples will be collected using an arterial line. There are no direct risks or benefits for patients included in the study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Cardiac surgery (isolated coronary artery bypass grafting or combined with single valve surgery, isolated single valve surgery)

• Gastrointestinal surgery (colorectal, pancreatic, gastric surgery).

• Vascular surgery (open and endovascular aortic surgery, peripheral vascular surgery)

• Lung surgery (pneumonectomy,(bi)(sleeve)lobectomy or segmentectomy)

Locations
Other Locations
Netherlands
Amphia Hospital
RECRUITING
Breda
St Antonius Hospital
RECRUITING
Nieuwegein
Contact Information
Primary
Peter Noordzij
p.noordzij@antoniusziekenhuis.nl
0031883203000
Backup
Thijs Rettig
trettig@amphia.nl
0031883203000
Time Frame
Start Date: 2021-10-12
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 5000
Related Therapeutic Areas
Sponsors
Collaborators: Roche Diagnostics GmbH
Leads: St. Antonius Hospital

This content was sourced from clinicaltrials.gov