Biomarkers in Perioperative Management (BIGPROMISE)

April 22, 2026 updated by: dr. P. Noordzij, St. Antonius Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • North Brabant
      • Breda, North Brabant, Netherlands, 4818CK
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3430 EM
        • Recruiting
        • St Antonius Hospital
        • Contact:
          • Peter Noordzij
          • Phone Number: 0031883203000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients undergoing surgery in the St. Antonius Hospital and the Amphia hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complication
Time Frame: 30 days
a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Collaborators

Roche Diagnostics GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL7407610020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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