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Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395951
Recruitment Status : Completed
First Posted : January 10, 2018
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
Erasmus Medical Center
Information provided by (Responsible Party):
L.P.B. Meijs, 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.

Condition or disease Intervention/treatment
Sepsis Heart Failure Heart Diseases Septic Shock Surgery Critically Ill Drug: Diuretics

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.

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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Observation of Mean Systemic Filling Pressure in Critical Care Patients With Continuous Diuretics Administration
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : October 1, 2014
Actual Study Completion Date : January 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care


Intervention Details:
  • Drug: Diuretics
    Observation of hemodynamics during diuretics treatment within clinical indication.
    Other Name: Diuretic therapy


Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill patients with a clinical indication for treatment with intravenous diuretics
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395951


Locations
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Netherlands
Catharina Hospital
Eindhoven, North Brabant, Netherlands, 5623 EJ
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Erasmus Medical Center
Investigators
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Study Chair: Jan Bakker, MD, PhD Erasmus Medical Center
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Responsible Party: L.P.B. Meijs, Principal investigator L.P.B. Meijs, MD, PhD-candidate Intensive Care Unit / resident cardiology, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT03395951    
Other Study ID Numbers: n-WMO 2014-43
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Under negotiable conditions sharing of data can be discussed.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Years
Access Criteria: Negotiable

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by L.P.B. Meijs, Catharina Ziekenhuis Eindhoven:
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
Additional relevant MeSH terms:
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Heart Diseases
Critical Illness
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Diuretics
Natriuretic Agents
Physiological Effects of Drugs