Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Observation of Mean Systemic Filling Pressure in Critical Care Patients With Continuous Diuretics Administration

Conditions
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Sepsis, Heart Failure, Heart Diseases, Septic Shock, Surgery, Critically Ill

Intervention / Treatment
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* Drug: Diuretics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be at least 18 years PiCCO in situ (cardiac output device applied in light of clinical treatment) CVL in situ Clinical indication for continuous furosemide administration Exclusion Criteria: Patients younger then 18 years Patients without PiCCO Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Diuretics|Observation of hemodynamics during diuretics treatment within clinical indication.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline and after 24 hours | 
| Creatinin (renal function) mmol/L | Increase/decrease in creatinin (standard blood withdrawal within standard ICU treatment) | 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) | Baseline and after 24 hours | 
| Diuresis per hour (mL/hour) | Increase/decrease in diuresis (standardly measured within standard ICU treatment) | Baseline, 1 hour, 2 hours and after 24 hours | 
| Body weight (kg) | Increase/decrease in body weight (standardly measured within standard ICU treatment) | Baseline and after 24 hours | 
| Fluid balance (mL) | Increase/decrease in fluid balance (mL) (standardly measured within standard ICU treatment) | Baseline and after 24 hours | 
| Change in cardiac performance (eH) (dimensionless) | Increase/decrease in cardiac performance (eH) | Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mean Systemic Filling Pressure, Diuretics, Pressure for venous return, Fluid Balance, De-escalation fluid therapy, De-resuscitation, Guyton, Guytonian Approach, Furosemide, Cardiac Output, Cardiac Index