The purpose of this study is to evaluate the effectiveness of using the personal preoperatively assessed cardiac output in high-risk patients to guide perioperative administration of fluids and vasoactive drugs on predefined postoperative complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
188
Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Number of study participants with at least one complication of a composite of 30-day postinterventional complications
composite of 30-day postinterventional complications defined according to the ESA-ESICM guidelines for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine (acute kidney injury stage 1 or higher \[KIDGO\]; ARDS; anastomotic breakdown \[moderate and severe\]; arrhythmia \[severe\]; cardiac arrest; cardiogenic pulmonary oedema \[severe\]; deep vein thrombosis \[moderate and severe\]; delirium; GI bleeding \[severe\]; Infection, source uncertain \[severe\]; bloodstream infection \[severe\]; myocardial infarction \[severe\]; pneumonia \[severe\]; paralytic ileus \[severe\]; postoperative haemorrhage \[severe\]; pulmonary embolism \[severe\]; stroke \[severe\]; superficial, deep, organ/space surgical site infection \[severe\]; urinary tract infection \[severe\]; death)
Time frame: up tp 90 days after study enrollment
7-day-mortality
Time frame: up to 7 days after study enrollment
30-day-mortality
Time frame: up to 30 days after study enrollment
90-day-mortality
Time frame: up to 90 days after study enrollment
ICU length of stay
Time frame: up to 90 days after study enrollment
hospital length of stay
Time frame: up to 90 days after study enrollment
postoperative morbidity survey on days 3, 7, 14, 30
Time frame: up to 90 days after study enrollment
postoperative cognitive dysfunction
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from day 3 after surgical intervention
Time frame: up to 90 days after study enrollment
Biomarkers of the vascular function as prognostic parameters for immunological complications (syndecan 1, sphingosine 1-phosphate, asymmetric dimethylarginine [ADMA], symmetric dimethylarginine [SDMA], arginine, homoarginine
Time frame: up to 90 days after study enrollment
perioperative changes of primary metabolites [e. g. citric acid cycle, glycolysis, amino acids metabolism], lipid and phospholipid mediators
Time frame: up to 90 days after study enrollment