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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03395951
Other study ID # n-WMO 2014-43
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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