Biomarkers in Perioperative Management

Recruiting

• Conditions: Death; Postoperative Complications; Quality of Life

• Registration Number: NCT05199025
• Lead Sponsor: St. Antonius Hospital

Brief Summary

Rationale: The rate of postoperative complications after high-risk surgery remains high despite recent advances in perioperative management. There is a lack of objective and reliable information that can be used for risk stratification and to guide treatment decisions.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-12
• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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).
• 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative complication	30 days	a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death

Secondary Outcome Measures

Name	Time	Method
DAH120	120 days	Days alive and out of hospital
Failure to rescue	30 days	In-hospital death following a major complication
Mortality	120 days	Death
Disability	120 days	Change in disability according to WHODAS 2.0 - 12 item

Trial Locations

Locations (2)

Amphia Hospital; 🇳🇱 Breda, Brabant, Netherlands

St Antonius Hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands