grote buik operaties anesthesiology major abdominal surgery
Conditions
Interventions
In patients assigned to personalized hemodynamic management, intraoperative
cardiac index will be maintained at least at the preoperative baseline cardiac
index. Patients assigned to personalized he
Sponsors
University Medical Center Hamburg-Eppendorf
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Consenting patients >=45 years who are scheduled for elective major abdominal surgery under general anesthesia that is expected to last >=90 minutes AND who have >=1 of the following high-risk criteria: * Exercise tolerance =1.3 mg dL-1 or estimated glomerular filtration rate =II) * Valvular heart disease (moderate or severe) * History of stroke * Peripheral arterial occlusive disease (any stage) * Chronic obstructive pulmonary disease (any stage) or pulmonary fibrosis (any stage) * Diabetes mellitus requiring oral hypoglycemic agent or insulin * Immunodeficiency due to a disease (e.g., HIV, leukemia, multiple myeloma) or therapy (e.g., immunosuppressants, chemotherapy, radiation, steroids [above Cushing threshold]) * Liver cirrhosis (any Child-Pugh class) * Body mass index >=30 kg m-2 * History of smoking within two years of surgery * Age >=65 years * Expected anesthesia duration >=180 minutes * B-type natriuretic peptide (BNP) >80 ng/L or N-terminal B-type natriuretic peptide (NT-proBNP) >200 ng/L within the last 6 months
Exclusion criteria
Exclusion criteria: * Emergency surgery * Planned surgery: nephrectomy, liver or kidney transplantation surgery * Status post transplantation of kidney, liver, heart, or lung * Sepsis (according to current Sepsis-3 definition) * American Society of Anesthesiologists physical status classification V or VI * Pregnancy * Impossibility to perform cardiac index monitoring using the Starling Fluid Management System (Baxter, Deerfield, IL, USA) * Current participation in another clinical trial of a treatment with a similar biological mechanism or primary outcome measure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collapsed composite endpoint (*any event versus none*) of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, severe infectious complications, and death within 7 days after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Incidence of the composite primary outcome within 3 days after surgery * Incidences of each of the individual components of the primary outcome within 3 and 7 days after surgery * Individual incidences of fever, respiratory infection, neurological infection, urinary system infection, colitis or infection with Clostridium difficile, endometritis, surgical site infection, deep incisional surgical site infection, organ or space surgical site infection, unknown infection with pathogenic organisms in tissue or fluid, and sepsis within 7 days after surgery * Collapsed incidence and individual incidences of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 30 days and 90 days after surgery * Time-to-event endpoint with the event *transfer from intensive care unit to normal ward* within 90 days after surgery * Time-to-event endpoint with the event *hospital discharge* within 90 days after surgery * Incidence of unplanned hospital re-admission within 30 days after surgery | — |
Countries
Netherlands
Outcome results
None listed