Clinical trial NCT03395951: Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients
Official title: Clinical Observation of Mean Systemic Filling Pressure in Critical Care Patients With Continuous Diuretics Administration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Heart Failure
Heart Diseases
Septic Shock
Surgery
Critically Ill
Keywords: 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
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2018-01-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients with a clinical indication for treatment with intravenous diuretics

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.

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

Primary outcomes:
measure: Change in mean systemic filling pressure (mmHg)
timeFrame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Secondary outcomes:
measure: Change in cardiac index (L/min/m2)
timeFrame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
measure: Change in mean arterial pressure (mmHg)
timeFrame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
measure: Change in central venous pressure (mmHg)
timeFrame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
measure: Change in pressure for venous return (mmHg)
timeFrame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
measure: Change in resistance to venous return (dynes⋅sec⋅cm-5)
timeFrame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
measure: Change in systemic vascular resistance index (dynes⋅sec⋅cm-5)
timeFrame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
measure: Change in venous return index (L/min/m2)
timeFrame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
measure: Change in heart rate (bpm)
timeFrame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
measure: Change in extra vascular lung water index (mL/kg)
timeFrame: Baseline and after 24 hours
measure: Change in global end diastolic volume index (mL/m2)
timeFrame: Baseline and after 24 hours
measure: Change in intrathoracic blood volume index (mL/m2)
timeFrame: Baseline and after 24 hours
measure: Creatinin (renal function) mmol/L
timeFrame: Baseline and after 24 hours
measure: Electrolyte balance (potassium, sodium levels) (mmol/L)
timeFrame: Baseline and after 24 hours
measure: Diuresis per hour (mL/hour)
timeFrame: Baseline, 1 hour, 2 hours and after 24 hours
measure: Body weight (kg)
timeFrame: Baseline and after 24 hours
measure: Fluid balance (mL)
timeFrame: Baseline and after 24 hours
measure: Change in cardiac performance (eH) (dimensionless)
timeFrame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: North Brabant
Study officials:
affiliation: Erasmus Medical Center
name: Jan Bakker, MD, PhD
role: STUDY_CHAIR
References: