Biomarkers to guide perioperative management and improve outcome in high-risk surgery

Biomarkers to guide perioperative management and improve outcome in high-risk surgery - BIG PROMISE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54308

Enrollment

4819

Registered

2020-05-11

Start date

2021-10-12

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse event Complication

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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, hyperthermic intraperitoneal chemotherapy). - Vascular surgery (open and endovascular aortic surgery, peripheral vascular surgery) - Lung surgery (pneumonectomy,(bi)(sleeve)lobectomy or segmentectomy)

Exclusion criteria

Exclusion criteria: - Age

Design outcomes

Primary

Measure	Time frame
Main study parameters are levels of PCT, CRPhs, IL-6, GDF-15, sFLT, NT-proBNP, cTNThs, CysC and NGAL. The primary outcome parameter is a major postoperative complication (within 30 days of surgery) and includes surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiac events and all-cause mortality	—

Secondary

Measure	Time frame
Secondary study parameters are levels of Hb, Ht, MCV, RDW, reticulocytes, thrombocytes, leucocytes, MPV, urea, creatinine, sodium, potassium, chloride, calcium, phosphate, magnesium, ASAT, ALAT, LDH, ALP, gamma GT, bilirubin, CK, albumin, glucose, Cholesterol, Triglycerides, HDL-cholesterol, LDL-cholesterol, serum iron, ferritin, transferrin saturation. vitamin D, TSH, FT4, igf-1, SHBG. Secondary study endpoints are: Duration of ICU stay ICU readmission ICU mortality Failure to rescue Duration of hospital stay Hospital readmission Hospital mortality 30-day mortality 120-day mortality 1-year mortality 2-year mortality Days alive and out of the hospital at 120 days Myocardial injury Change in disability (measured with the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12-item version)	—

Measure

Time frame

Secondary study parameters are levels of Hb, Ht, MCV, RDW, reticulocytes, thrombocytes, leucocytes, MPV, urea, creatinine, sodium, potassium, chloride, calcium, phosphate, magnesium, ASAT, ALAT, LDH, ALP, gamma GT, bilirubin, CK, albumin, glucose, Cholesterol, Triglycerides, HDL-cholesterol, LDL-cholesterol, serum iron, ferritin, transferrin saturation. vitamin D, TSH, FT4, igf-1, SHBG. Secondary study endpoints are: Duration of ICU stay ICU readmission ICU mortality Failure to rescue Duration of hospital stay Hospital readmission Hospital mortality 30-day mortality 120-day mortality 1-year mortality 2-year mortality Days alive and out of the hospital at 120 days Myocardial injury Change in disability (measured with the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12-item version)

—

Countries

Netherlands

Contacts

Public ContactJBL Meer

Antonius Ziekenhuis

p.noordzij@antoniusziekenhuis.nl088 320 69 48

Outcome results