The purpose of this study is to determine fluid responsiveness in critically ill patients by
measuring mean systemic filling pressure on the intensive care unit.
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Full eligibility criteria for NCT02778620
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patients must be older than 18 years, and must be equipped with a pulse-contour cardiac output system with a central venous catheter.
Patients will be subsequently connected to the hemodynamic monitoring device Navigator™.
In those patients with clinical signs of inadequate tissue perfusion, passive leg raising and standardized fluid challenge will be performed.
Patients with assist devices (e.g. intra aortic balloon pump, Impella®, ECMO), patients with arrhythmias (either atrial of ventricular) will be excluded from the study.
Also, patients with inguinal impairment or contraindications for a passive leg raising will be excluded (such as deep venous thrombosis or elastic compression stocking), head trauma, an increase intra-abdominal pressure suspected by clinical context and examination as well as patients with absolute contraindications for fluid challenge.
All locations for NCT02778620
Eindhoven, North Brabant, Netherlands, 5623 EJ
View full eligibility
Tris trial is registered with FDA with number: NCT02778620. The sponsor of the trial is Catharina Ziekenhuis Eindhoven and it is looking for 27 volunteers for the current phase.
Official trial title: Mean Systemic Filling Pressure and Heart Performance as Predictors of Successful Fluid Responsiveness in Patients With Aortic Valve Replacement
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