To describe the perioperative biomarker response in surgical patients with and without a postoperative complication.To construct a preoperative and postoperative prediction model for postoperative complications to improve risk stratification and…
ID
Source
Brief title
Condition
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background summary
There is an unmet need in perioperative medicine for adequately powered studies
that systematically target the association between perioperative biomarker
responses and postoperative complications. Currently, there is insufficient
knowledge of the pathophysiology of postoperative complications and a lack of
objective and reliable information that can be used for risk stratification and
guide treatment decisions. In addition, a scarcity exists of systematically
collected high quality outcome data in the surgical population undergoing
high-risk procedures. Biomarkers, both new and existing, can provide objective
molecular information to better understand the pathophysiology of postoperative
complications and can help to improve risk stratification and facilitate health
care improvements that aim to reduce the number of adverse events in high-risk
surgical patients.
Study objective
To describe the perioperative biomarker response in surgical patients with and
without a postoperative complication.
To construct a preoperative and postoperative prediction model for
postoperative complications to improve risk stratification and guide treatment
decisions in high-risk surgical patients.
Study design
Prospective observational multicentre cohort study
Study burden and risks
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. If an arterial line is not available, venipuncture will be
performed by a laboratory nurse according to standard operating procedures. A
venipuncture will be performed simultaneously with routine laboratory testing
that are a part of perioperative care, if applicable. The risks of a
venipuncture are minimal. They include discomfort at the puncture site,
bruising or swelling at the puncture site, or an infection of the skin.
Patients are asked to fill out a questionnaire pre-and postoperatively (5-10
minutes for each questionnaire).
Molengracht 21
Breda 4818 CK
NL
Molengracht 21
Breda 4818 CK
NL
Listed location countries
Age
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
- Age < 18 years - Pregnancy - Emergent surgery - No informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74076.100.20 |