Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Heart Failure; Sepsis; Septic Shock; Surgery; Critically Ill
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Netherlands
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5623 EJ
      • Catharina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically ill patients with a clinical indication for treatment with intravenous diuretics

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Collaborators: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2014
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): January 31, 2015

Study Registration Dates

• First Submitted: January 1, 2018
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (ACTUAL): January 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Diuretics; Furosemide; Fluid Balance; Cardiac Output; Mean Systemic Filling Pressure; Cardiac Index; Pressure for venous return; De-escalation fluid therapy; De-resuscitation; Guyton; Guytonian Approach
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Disease Attributes; Heart Diseases; Critical Illness; Physiological Effects of Drugs; Natriuretic Agents; Diuretics
• Other Study ID Numbers: n-WMO 2014-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Under negotiable conditions sharing of data can be discussed.
• IPD Sharing Time Frame: Years
• IPD Sharing Access Criteria: Negotiable
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No