Catharina Hospital
Eindhoven, North Brabant, 5623 EJ, Netherlands
NCT Number: NCT03395951
Within clinical settings observation of hemodynamic changes (e.g. mean systemic filling pressure, cardiac output) in critically ill patients with a clinical indication for deresuscitation with intravenous diuretic therapy.
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Notify Me18 year and older
All sexes
Observational
Eindhoven, North Brabant, 5623 EJ, Netherlands
Rationale: The assessment of the cardiovascular state in critically ill patients is subject to difficulties in terms of the fact that several hemodynamic parameters, for example mean arterial blood pressure (MAP) and cardiac output (CO) supply insufficient information about the circulating volume and cardiac performance. There is a clinical need for adequate determination of intravascular volume status. However, in determining the intravascular fluid status of a patient, the lack of appreciation of the venous side of the circulation persists today, which is greatly due to the inability to appropriately assess the venous side of the circulation. The importance of the venous part of the circulation is moreover reflected by the fact that an increase in venous resistance does reduce CO many times more than a similar increase in arterial resistance. Mean systemic filling pressure (Pms), which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment.
Positive fluid balance and /or substantial weight gain in critically ill patients is a common problem in the intensive care unit (ICU), potentially associated with a poor outcome. This problem, in association with hemodynamic instability and increase of creatinin, ureum and sodium, may lead to peripheral edema. Furosemide, a loop diuretic, is frequently administered to critically ill patients to increase urine output and to relieve edema.
Objective: Observing changes in Pms during continuous furosemide administration.
Study design: Prospective, observational study Study population: Patients with a PICCO® system with a positive fluid balance and / or substantial weight gain and therefore with a clinical indication for diuretic therapy.
Intervention: Continuous furosemide administration. Main study parameters/endpoints: Pms measured at baseline, changes in Pms during continuous furosemide administration.
Adverse events: No risks involved.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Observation of hemodynamics during diuretics treatment within clinical indication.
Other names: Diuretic therapy
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Decrease or increase in mean systemic filling pressure measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Decrease/increase in cardiac index measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Decrease/increase in mean arterial pressure measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Decrease/increase in central venous pressure measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Decrease/increase in pressure for venous return measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Decrease/increase in resistance te venous return measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Decrease/increase in systemic vascular resistance index measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Decrease/increase in venous return index measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Decrease/increase in heart rate measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Time frame: Baseline and after 24 hours
Decrease/increase in extra vascular lung water index measured with continuous cardiac output monitoring PiCCO(R) device
Time frame: Baseline and after 24 hours
Decrease/increase in global end diastolic volume index measured with continuous cardiac output monitoring PiCCO(R) device
Time frame: Baseline and after 24 hours
Decrease/increase in intrathoracic blood volume index measured with continuous cardiac output monitoring PiCCO(R) device
Time frame: Baseline and after 24 hours
Increase/decrease in creatinin (standard blood withdrawal within standard ICU treatment)
Time frame: Baseline and after 24 hours
Increase/decrease in electrolyte balance (potassium, sodium levels) (standard blood withdrawal within standard ICU treatment)
Time frame: Baseline, 1 hour, 2 hours and after 24 hours
Increase/decrease in diuresis (standardly measured within standard ICU treatment)
Time frame: Baseline and after 24 hours
Increase/decrease in body weight (standardly measured within standard ICU treatment)
Time frame: Baseline and after 24 hours
Increase/decrease in fluid balance (mL) (standardly measured within standard ICU treatment)
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Increase/decrease in cardiac performance (eH)
Catharina Ziekenhuis Eindhoven
Other
Clinical Observation of Mean Systemic Filling Pressure in Critical Care Patients With Continuous Diuretics Administration
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