Postoperative ComplicationsBIGPROMISENCT05199025
Biomarkers in Perioperative Management
An observational study of Postoperative Complications and Quality of Life, run by St. Antonius Hospital at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Quality of Life, Death
- What is being tested?
- Biomarker
- How many people
- 5,000 participants
- Where
- 2 sitesNetherlands
- Study dates
- 12 Oct 2021to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients undergoing surgery in the St. Antonius Hospital and the Amphia hospital.
Who may be able to join
- 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)
Who cannot join
- Age < 18 years
- Pregnancy
- Emergent surgery
- No informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Amphia Hospital
Breda, North Brabant, 4818CK
Thijs Rettig, trettig@amphia.nl
- Recruiting
St Antonius Hospital
Nieuwegein, Utrecht, 3430 EM
Peter Noordzij, 0031883203000
About this study
Official title: 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.
Read more
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.
- Conditions
- Postoperative Complications, Quality of Life, Death
- Being tested
- Biomarker
- Medical subject headings
- Postoperative Complications, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiomarkerDiagnostic test
Perioperative biomarker analyses
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication
a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death
Measured: 30 days
Secondary outcomes (4)
Failure to rescue
In-hospital death following a major complication
Measured: 30 days
Mortality
Death
Measured: 120 days
DAH120
Days alive and out of hospital
Measured: 120 days
Disability
Change in disability according to WHODAS 2.0 - 12 item
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start12 Oct 2021
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Principal investigator, dr. P. Noordzij, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199025
- Sponsor's protocol ID
- NL7407610020
- Acronym
- BIGPROMISE
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2022
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Reniers T, Noordzij P, Harding E, Ruven H, Thio M, Langelaan M, Dijkstra I, Vernooij L, Cremer O, Rettig TCD. Procalcitonin and interleukin-6 to diagnose infection in cardiac surgery patients with hyperinflammation: a two-centre, prospective cross-sectional study. BJA Open. 2026 Feb 19;17:100538. doi: 10.1016/j.bjao.2026.100538. eCollection 2026 Mar.
PubMed 41768076Noordzij PG, Ruven HJ, Reniers T, Idema RN, Thio MS, Cremer OL, Hollema N, Smit KN, Vernooij LM, Dijkstra IM, Rettig TC. Cohort profile of BIGPROMISE: a perioperative biobank of a high-risk surgical population. BMJ Open. 2024 Jun 11;14(6):e078307. doi: 10.1136/bmjopen-2023-078307.
PubMed 38862228
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers to Guide Perioperative Management and Improve Outcome in High-risk Surgery
- ClinicalTrials.gov ID
- NCT05199025
- Acronym / sponsor ID
- BIGPROMISE / NL7407610020
- Conditions
- Postoperative Complications, Quality of Life, Death
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients undergoing surgery in the St. Antonius Hospital and the Amphia hospital.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- Age < 18 years
- Pregnancy
- Emergent surgery
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiomarkerPerioperative biomarker analyses | Diagnostic test | – |
Primary outcome
Postoperative complication
Time frame: 30 days
a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death
4 secondary outcomes
Failure to rescue
Time frame: 30 days
Mortality
Time frame: 120 days
DAH120
Time frame: 120 days
Disability
Time frame: 120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 41768076Reniers T, Noordzij P, Harding E, Ruven H, Thio M, Langelaan M, Dijkstra I, Vernooij L, Cremer O, Rettig TCD. Procalcitonin and interleukin-6 to diagnose infection in cardiac surgery patients with hyperinflammation: a two-centre, prospective cross-sectional study. BJA Open. 2026 Feb 19;17:100538. doi: 10.1016/j.bjao.2026.100538. eCollection 2026 Mar.
- Derived from this study: PubMed 38862228Noordzij PG, Ruven HJ, Reniers T, Idema RN, Thio MS, Cremer OL, Hollema N, Smit KN, Vernooij LM, Dijkstra IM, Rettig TC. Cohort profile of BIGPROMISE: a perioperative biobank of a high-risk surgical population. BMJ Open. 2024 Jun 11;14(6):e078307. doi: 10.1136/bmjopen-2023-078307.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Quality of Life, run by St. Antonius Hospital at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Noordzij (0031883203000, p.noordzij@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complication (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05199025, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.