Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-01

Study Completion Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Sepsis Heart Failure Heart Diseases Septic Shock Surgery Critically Ill

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Diuretics

Observation of hemodynamics during diuretics treatment within clinical indication.

Intervention Type DRUG

Other Intervention Names

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Diuretic therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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L.P.B. Meijs

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Bakker, MD, PhD

Role: STUDY_CHAIR

Erasmus Medical Center

Locations

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Catharina Hospital

Eindhoven, North Brabant, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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n-WMO 2014-43

Identifier Type: -

Identifier Source: org_study_id