Phase
Condition
Surgery
Anesthesia
Treatment
Personalized hemodynamic management
Clinical Study ID
Ages > 45 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Consenting patients ≥45 years scheduled for elective major abdominal surgery (involving visceral organs) under general anesthesia that is expected to last ≥90 minutes AND presence of ≥1 of the following high-risk criteria:
exercise tolerance <4 metabolic equivalents as defined by the guidelines of theAmerican College of Cardiology/American Heart Association
renal impairment (serum creatinine ≥1.3 mg dL-1 or estimated glomerular filtrationrate <90 mL min-1 (1.73 m2)-1 within the last 6 months
coronary artery disease
chronic heart failure (New York Heart Association Functional Classification ≥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 Cushingthreshold])
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 surgery 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
Exclusion Criteria:
emergency surgery
ambulatory 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 FluidManagement System (Baxter, Deerfield, IL, USA)
current participation in another clinical trial or treatment with a similarbiological mechanism or primary outcome measure
Study Design
Study Description
Connect with a study center
Medical University of Graz
Graz 2778067,
AustriaSite Not Available
University Hospital Plzen
Pilsen 3068160,
CzechiaSite Not Available
Hvidovre Hospital
Copenhagen,
DenmarkActive - Recruiting
University Medical Center Copenhagen Bispebjerg and Frederiksberg
Copenhagen,
DenmarkActive - Recruiting
Hvidovre Hospital
Copenhagen 2618425,
DenmarkSite Not Available
Rigshospitalet
Copenhagen 2618425,
DenmarkSite Not Available
University Medical Center Copenhagen Bispebjerg and Frederiksberg
Copenhagen 2618425,
DenmarkSite Not Available
University Hospital RWTH Aachen
Aachen 3247449,
GermanySite Not Available
University Hospital Düsseldorf
Düsseldorf 2934246,
GermanySite Not Available
University Medical Center Hamburg
Hamburg 2911298,
GermanySite Not Available
University Medical Center Schleswig Holstein, Lübeck
Lübeck 2875601,
GermanySite Not Available
University Hospital Marburg
Marburg 2873759,
GermanySite Not Available
LMU Munich
Munich 2867714,
GermanySite Not Available
Clínica Universidad de Navarra
Pamplona 3114472,
SpainSite Not Available

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