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Completed

NCT Number: NCT02060942

Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness

Determining fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mean systemic filling pressure (Pms)

    Time frame: 1 hour

    An increase in mean systemic filling pressure after (self)volume-challenge indicating volume responsiveness of the patient

Secondary outcomes

  1. Heart performance (eH)

    Time frame: 1 hour

    Quotient of driving pressure of venous return in mmHg

Other outcomes

  1. Secondary hemodynamic parameters

    Time frame: 1 hour

    Heart Rate

  2. Secondary hemodynamic parameters

    Time frame: 1 hour

    Mean Arterial Blood Pressure

  3. Secondary hemodynamic parameters

    Time frame: 1 hour

    Cardiac Index

  4. Secondary hemodynamic parameters

    Time frame: 1 hour

    Central Venous Pressure

  5. Secondary hemodynamic parameters

    Time frame: 1 hour

    Systemic Vascular Resistance

  6. Secondary hemodynamic parameters

    Time frame: 1 hour

    Pulse Pressure Variation

  7. Secondary hemodynamic parameters

    Time frame: 1 hour

    Pulmonary Vascular Permeability Index

  8. Secondary hemodynamic parameters

    Time frame: 1 hour

    Plethysmographic Oxygen Saturation

  9. Secondary hemodynamic parameters

    Time frame: 1 hour

    Delivery of Oxygen Index

  10. Secondary hemodynamic parameters

    Time frame: 1 hour

    Mechanical Ventilation Settings

  11. Secondary hemodynamic parameters

    Time frame: 1 hour

    End-tidal CO2

  12. Secondary hemodynamic parameters

    Time frame: 1 hour

    Peripheral Temperature

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Collaborators

  • Erasmus Medical Center

Registry information

Official study title

Mean Systemic Filling Pressure and Heart Performance as Predictors of Successful Fluid Responsiveness in Patients With Coronary Artery Bypass Grafting

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 12, 2014
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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