Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients

Completed

• Conditions: Heart Failure; Critically Ill; Sepsis; Heart Diseases; Septic Shock; Surgery

• Registration Number: NCT03395951
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-10-01
• Primary Completion: 2014-10-01
• Study Completion: 2015-01-31
• Study First Submitted: 2018-01-01
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-10
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mean systemic filling pressure (mmHg)	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

Secondary Outcome Measures

Name	Time	Method
Change in cardiac index (L/min/m2)	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
Change in mean arterial pressure (mmHg)	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
Change in central venous pressure (mmHg)	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
Change in pressure for venous return (mmHg)	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
Change in extra vascular lung water index (mL/kg)	Baseline and after 24 hours	Decrease/increase in extra vascular lung water index measured with continuous cardiac output monitoring PiCCO(R) device
Change in intrathoracic blood volume index (mL/m2)	Baseline and after 24 hours	Decrease/increase in intrathoracic blood volume index measured with continuous cardiac output monitoring PiCCO(R) device
Creatinin (renal function) mmol/L	Baseline and after 24 hours	Increase/decrease in creatinin (standard blood withdrawal within standard ICU treatment)
Change in resistance to venous return (dynes⋅sec⋅cm-5)	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
Change in systemic vascular resistance index (dynes⋅sec⋅cm-5)	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
Change in heart rate (bpm)	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
Change in venous return index (L/min/m2)	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
Change in global end diastolic volume index (mL/m2)	Baseline and after 24 hours	Decrease/increase in global end diastolic volume index measured with continuous cardiac output monitoring PiCCO(R) device
Diuresis per hour (mL/hour)	Baseline, 1 hour, 2 hours and after 24 hours	Increase/decrease in diuresis (standardly measured within standard ICU treatment)
Body weight (kg)	Baseline and after 24 hours	Increase/decrease in body weight (standardly measured within standard ICU treatment)
Fluid balance (mL)	Baseline and after 24 hours	Increase/decrease in fluid balance (mL) (standardly measured within standard ICU treatment)
Electrolyte balance (potassium, sodium levels) (mmol/L)	Baseline and after 24 hours	Increase/decrease in electrolyte balance (potassium, sodium levels) (standard blood withdrawal within standard ICU treatment)
Change in cardiac performance (eH) (dimensionless)	Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours	Increase/decrease in cardiac performance (eH)

Trial Locations

Locations (1)

Catharina Hospital; 🇳🇱 Eindhoven, North Brabant, Netherlands