Clinical trial NCT02778620: Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness in Aortic Valve Replacement
Official title: Mean Systemic Filling Pressure and Heart Performance as Predictors of Successful Fluid Responsiveness in Patients With Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output, High
Keywords: Volume responsiveness mean systemic filling pressure
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2016-05-20
Enrollment: 27
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: Post-aortic valve replacement patients

Brief summary: The purpose of this study is to determine fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit.

Detailed description: 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 to adequate determination of intravascular volume status and therefore reliable predictors of fluid responsiveness are highly relevant. However, in determining the 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. Passive leg raising (PLR) represents a "self-volume challenge" that predicts preload responsiveness and the transient hemodynamic changes on venous return can be directly monitored in ventilated patients, provided that there is an intact circulation, in order to test the amount of volume responsiveness.

Eligibility criteria: Inclusion Criteria:

* Patients must be older than 18 years, and must be equipped with a pulse-contour cardiac output system with a central venous catheter.
* Patients will be subsequently connected to the hemodynamic monitoring device Navigator™.
* In those patients with clinical signs of inadequate tissue perfusion, passive leg raising and standardized fluid challenge will be performed.

Exclusion Criteria:

* Patients with assist devices (e.g. intra aortic balloon pump, Impella®, ECMO), patients with arrhythmias (either atrial of ventricular) will be excluded from the study.
* Also, patients with inguinal impairment or contraindications for a passive leg raising will be excluded (such as deep venous thrombosis or elastic compression stocking), head trauma, an increase intra-abdominal pressure suspected by clinical context and examination as well as patients with absolute contraindications for fluid challenge.

Primary outcomes:
measure: Mean systemic filling pressure (Pms)
timeFrame: 1 hour
Secondary outcomes:
measure: Heart performance (eH)
timeFrame: 1 hour
Other outcomes:
measure: Heart Rate
timeFrame: 1 hour
measure: MAP
timeFrame: 1 hour
measure: CI
timeFrame: 1 hour
measure: CVP
timeFrame: 1 hour
measure: SVR
timeFrame: 1 hour
measure: PPV
timeFrame: 1 hour
measure: PVPI
timeFrame: 1 hour
measure: pO2
timeFrame: 1 hour
measure: DO2I
timeFrame: 1 hour
measure: Ventilation
timeFrame: 1 hour
measure: etCO2
timeFrame: 1 hour
measure: Temp perif
timeFrame: 1 hour
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: