380
Participants
Start Date
August 29, 2017
Primary Completion Date
March 27, 2023
Study Completion Date
August 26, 2023
Individualized Goal Directed Therapy
The trial intervention period will commence from the induction of anesthesia until 8 hours after surgery, or until discharging from the postoperative intensive or intermediate care unit. All patients in the intervention group receive basic vital sign monitoring. For inotropic support dobutamine, and as vasopressor norepinephrine are drugs of choice. Hemodynamic management is performed according to standard treatment until an arterial line is placed. The signal of the arterial line is then processed either by calibrated or non-calibrated pulse contour analysis for pulse pressure variation (PPV) and cardiac index (CI) measurement. Fluid challenge will be performed by infusion of 500 ml in \<15 minute. Choice of fluid in case of indicated fluid loading is determined on basis of the recent guideline for intravasal volume therapy. Patients receive fluids and vasoactive agents following a protocol of individualized parameters regularly achieved by extended hemodynamic monitoring.
Control Group
Patients in the control group will be treated according to established basic treatment goals (heart rate \<100 bpm, mean arterial pressure \>65 mmHg, SpO2\>94%, and core temperature \>36° C). Basic anesthesiological monitoring by five-lead-electrocardiogram, pulse oximetry, non-invasive blood pressure monitoring and capnography is performed in every patient of the control group. Placement of an arterial and central venous line, as well as fluid and catecholamines administration, are at the discretion of the treating clinician.
University Medical Center Hamburg-Eppendorf, Hamburg
Justus-Liebig-University Giessen, Giessen
University Medicine Rostock, Rostock
Università degli Studi di Ferrara, Ferrara
Università degli Studi di Genova, Genoa
Hospital Santa Creu i Sant Pau, Barcelona
Hospital Universitari i Politécnic La Fe, Valencia
University of Giessen
OTHER
University of Rostock
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER