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Clinical Trials/NCT03395951
NCT03395951
Completed
Not Applicable

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

Catharina Ziekenhuis Eindhoven1 site in 1 country18 target enrollmentOctober 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
Catharina Ziekenhuis Eindhoven
Enrollment
18
Locations
1
Primary Endpoint
Change in mean systemic filling pressure (mmHg)
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2014
End Date
January 31, 2015
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Catharina Ziekenhuis Eindhoven
Responsible Party
Principal Investigator
Principal Investigator

L.P.B. Meijs

Principal investigator L.P.B. Meijs, MD, PhD-candidate Intensive Care Unit / resident cardiology

Catharina Ziekenhuis Eindhoven

Eligibility 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

Outcomes

Primary Outcomes

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

  • Change in cardiac index (L/min/m2)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
  • Change in mean arterial pressure (mmHg)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
  • Change in central venous pressure (mmHg)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
  • Change in pressure for venous return (mmHg)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
  • Change in extra vascular lung water index (mL/kg)(Baseline and after 24 hours)
  • Change in intrathoracic blood volume index (mL/m2)(Baseline and after 24 hours)
  • Creatinin (renal function) mmol/L(Baseline and after 24 hours)
  • Change in resistance to venous return (dynes⋅sec⋅cm-5)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
  • Change in systemic vascular resistance index (dynes⋅sec⋅cm-5)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
  • Change in heart rate (bpm)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
  • Change in venous return index (L/min/m2)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
  • Change in global end diastolic volume index (mL/m2)(Baseline and after 24 hours)
  • Diuresis per hour (mL/hour)(Baseline, 1 hour, 2 hours and after 24 hours)
  • Body weight (kg)(Baseline and after 24 hours)
  • Fluid balance (mL)(Baseline and after 24 hours)
  • Electrolyte balance (potassium, sodium levels) (mmol/L)(Baseline and after 24 hours)
  • Change in cardiac performance (eH) (dimensionless)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)

Study Sites (1)

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