An observational study in Sepsis, Heart Failure and Heart Diseases, sponsored by Catharina Ziekenhuis Eindhoven. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by Catharina Ziekenhuis Eindhoven · Observational
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.
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.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's enrollment of 18 is below the median of 160 across 957 observational studies indexed under Sepsis.
Browse Sepsis studies →Catharina Ziekenhuis Eindhoven is the lead sponsor of 85 studies on the registry; 16 are open to participants now.
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Critically ill patients with a clinical indication for treatment with intravenous diuretics
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Observation of hemodynamics during diuretics treatment within clinical indication.
Also known as: Diuretic therapy
Change in mean systemic filling pressure (mmHg)
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
Change in cardiac index (L/min/m2)
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
Change in mean arterial pressure (mmHg)
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
Change in central venous pressure (mmHg)
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
Change in pressure for venous return (mmHg)
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
Change in resistance to venous return (dynes⋅sec⋅cm-5)
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
Change in systemic vascular resistance index (dynes⋅sec⋅cm-5)
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
Change in venous return index (L/min/m2)
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
Change in heart rate (bpm)
Decrease/increase in heart rate 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
Change in extra vascular lung water index (mL/kg)
Decrease/increase in extra vascular lung water index measured with continuous cardiac output monitoring PiCCO(R) device
Time frame: Baseline and after 24 hours
Change in global end diastolic volume index (mL/m2)
Decrease/increase in global end diastolic volume index measured with continuous cardiac output monitoring PiCCO(R) device
Time frame: Baseline and after 24 hours
Change in intrathoracic blood volume index (mL/m2)
Decrease/increase in intrathoracic blood volume index measured with continuous cardiac output monitoring PiCCO(R) device
Time frame: Baseline and after 24 hours
Creatinin (renal function) mmol/L
Increase/decrease in creatinin (standard blood withdrawal within standard ICU treatment)
Time frame: Baseline and after 24 hours
Electrolyte balance (potassium, sodium levels) (mmol/L)
Increase/decrease in electrolyte balance (potassium, sodium levels) (standard blood withdrawal within standard ICU treatment)
Time frame: Baseline and after 24 hours
Diuresis per hour (mL/hour)
Increase/decrease in diuresis (standardly measured within standard ICU treatment)
Time frame: Baseline, 1 hour, 2 hours and after 24 hours
Body weight (kg)
Increase/decrease in body weight (standardly measured within standard ICU treatment)
Time frame: Baseline and after 24 hours
Fluid balance (mL)
Increase/decrease in fluid balance (mL) (standardly measured within standard ICU treatment)
Time frame: Baseline and after 24 hours
Change in cardiac performance (eH) (dimensionless)
Increase/decrease in cardiac performance (eH)
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Plan to share: Yes — Under negotiable conditions sharing of data can be discussed.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Years
Access criteria: Negotiable
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Catharina Ziekenhuis Eindhoven