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Completed

NCT Number: NCT03395951

Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diuretics

Drug

Observation of hemodynamics during diuretics treatment within clinical indication.

Other names: Diuretic therapy

Primary outcomes

  1. Change in mean systemic filling pressure (mmHg)

    Time frame: 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 outcomes

  1. Change in cardiac index (L/min/m2)

    Time frame: 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

  2. Change in mean arterial pressure (mmHg)

    Time frame: 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

  3. Change in central venous pressure (mmHg)

    Time frame: 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

  4. Change in pressure for venous return (mmHg)

    Time frame: 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

  5. Change in resistance to venous return (dynes⋅sec⋅cm-5)

    Time frame: 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

  6. Change in systemic vascular resistance index (dynes⋅sec⋅cm-5)

    Time frame: 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

  7. Change in venous return index (L/min/m2)

    Time frame: 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

  8. Change in heart rate (bpm)

    Time frame: 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

  9. Change in extra vascular lung water index (mL/kg)

    Time frame: Baseline and after 24 hours

    Decrease/increase in extra vascular lung water index measured with continuous cardiac output monitoring PiCCO(R) device

  10. Change in global end diastolic volume index (mL/m2)

    Time frame: Baseline and after 24 hours

    Decrease/increase in global end diastolic volume index measured with continuous cardiac output monitoring PiCCO(R) device

  11. Change in intrathoracic blood volume index (mL/m2)

    Time frame: Baseline and after 24 hours

    Decrease/increase in intrathoracic blood volume index measured with continuous cardiac output monitoring PiCCO(R) device

  12. Creatinin (renal function) mmol/L

    Time frame: Baseline and after 24 hours

    Increase/decrease in creatinin (standard blood withdrawal within standard ICU treatment)

  13. Electrolyte balance (potassium, sodium levels) (mmol/L)

    Time frame: Baseline and after 24 hours

    Increase/decrease in electrolyte balance (potassium, sodium levels) (standard blood withdrawal within standard ICU treatment)

  14. Diuresis per hour (mL/hour)

    Time frame: Baseline, 1 hour, 2 hours and after 24 hours

    Increase/decrease in diuresis (standardly measured within standard ICU treatment)

  15. Body weight (kg)

    Time frame: Baseline and after 24 hours

    Increase/decrease in body weight (standardly measured within standard ICU treatment)

  16. Fluid balance (mL)

    Time frame: Baseline and after 24 hours

    Increase/decrease in fluid balance (mL) (standardly measured within standard ICU treatment)

  17. Change in cardiac performance (eH) (dimensionless)

    Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours

    Increase/decrease in cardiac performance (eH)

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Collaborators

  • Erasmus Medical Center

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jan 10, 2018
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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