Biomarkers in Perioperative Management

Quality of Life Clinical Trial

— BIGPROMISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199025
• Other study ID #: NL7407610020
• Status: Recruiting
• Start date: October 12, 2021
• Est. completion date: December 1, 2026

Study information

• Verified date: March 2023
• Source: St. Antonius Hospital
• Contact: Peter Noordzij
• Phone: 0031883203000
• Email: p.noordzij[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Postoperative Complications
• Quality of Life

Intervention

Diagnostic Test:
• Biomarker
Perioperative biomarker analyses

Locations

Country	Name	City	State
Netherlands	Amphia Hospital	Breda	Brabant
Netherlands	St Antonius Hospital	Nieuwegein	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
St. Antonius Hospital	Roche Diagnostics

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complication	a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death	30 days
Secondary	Failure to rescue	In-hospital death following a major complication	30 days
Secondary	Mortality	Death	120 days
Secondary	DAH120	Days alive and out of hospital	120 days
Secondary	Disability	Change in disability according to WHODAS 2.0 - 12 item	120 days