The purpose of this study is to investigate the efficacy of target controlled fluid therapy with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in patients undergoing elective surgery of the pancreatic head. A third group receiving a balanced electrolyte solution (without colloidal volume replacement) will serve as a control for descriptive analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
63
Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin
Berlin, Germany
Klinik für Anästhesie, operative Intensivmedizin und Schmerztherapie, Humboldt Klinikum
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml)
Goal-directed (stroke volume) plasma volume therapy
Time frame: up to 8 hours
Second endpoint: Time until fully on oral (solid) diet (days)
Time frame: up to 15 days
haemodynamics, arterial blood gas analysis, laboratory data, postoperative nausea and vomiting, adverse events, nursing delirium screening scale, several injury scores
Time frame: up to 7 days
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