Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395951
• Other study ID #: n-WMO 2014-43
• Status: Completed
• Start date: October 1, 2014
• Est. completion date: January 31, 2015

Study information

• Verified date: December 2019
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 31, 2015
• Est. primary completion date: October 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Heart Diseases
• Heart Failure
• Sepsis
• Septic Shock
• Surgery

Intervention

Drug:
• Diuretics
Observation of hemodynamics during diuretics treatment within clinical indication.

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven	North Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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