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Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness

Sponsor
Catharina Ziekenhuis Eindhoven (Other)
Overall Status
Completed
CT.gov ID
NCT02060942
Collaborator
Erasmus Medical Center (Other)
40
Enrollment
1
Location
17
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Mean Systemic Filling Pressure and Heart Performance as Predictors of Successful Fluid Responsiveness in Patients With Coronary Artery Bypass Grafting
    Study Start Date :
    Aug 1, 2013
    Actual Primary Completion Date :
    Jan 1, 2015
    Actual Study Completion Date :
    Jan 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Coronary artery bypass grafting

    Post Anaesthetic Care Unit (PACU) patients treated with coronary artery bypass grafting (CABG) are highly eligible for this study. These are patients with an indication for fast track treatment (PACU) post-cardiac surgery with a good left ventricular ejection fraction without significant co-morbidity. The final decision for PACU-classification is taken by the responsible anaesthesiologist and intensivist in close collaboration with the cardiothoracic surgeon performing the operation, as well as the cardiologist.

    Outcome Measures

    Primary Outcome Measures

    1. Mean systemic filling pressure (Pms) [1 hour]

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

    Secondary Outcome Measures

    1. Heart performance (eH) [1 hour]

      Quotient of driving pressure of venous return in mmHg

    Other Outcome Measures

    1. Secondary hemodynamic parameters [1 hour]

      Heart Rate

    2. Secondary hemodynamic parameters [1 hour]

      Mean Arterial Blood Pressure

    3. Secondary hemodynamic parameters [1 hour]

      Cardiac Index

    4. Secondary hemodynamic parameters [1 hour]

      Central Venous Pressure

    5. Secondary hemodynamic parameters [1 hour]

      Systemic Vascular Resistance

    6. Secondary hemodynamic parameters [1 hour]

      Pulse Pressure Variation

    7. Secondary hemodynamic parameters [1 hour]

      Pulmonary Vascular Permeability Index

    8. Secondary hemodynamic parameters [1 hour]

      Plethysmographic Oxygen Saturation

    9. Secondary hemodynamic parameters [1 hour]

      Delivery of Oxygen Index

    10. Secondary hemodynamic parameters [1 hour]

      Mechanical Ventilation Settings

    11. Secondary hemodynamic parameters [1 hour]

      End-tidal CO2

    12. Secondary hemodynamic parameters [1 hour]

      Peripheral Temperature

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Catharina Hospital Eindhoven North Brabant Netherlands 5623 EJ

    Sponsors and Collaborators

    • Catharina Ziekenhuis Eindhoven
    • Erasmus Medical Center

    Investigators

    • Study Chair: Jan Bakker, PhD, Erasmus University Hospital Rotterdam The Netherlands

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    L.P.B. Meijs, MD, PhD-candidate Intensive Care Unit / resident cardiology, Catharina Ziekenhuis Eindhoven
    ClinicalTrials.gov Identifier:
    NCT02060942
    Other Study ID Numbers:
    • M12-1271
    First Posted:
    Feb 12, 2014
    Last Update Posted:
    May 19, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by L.P.B. Meijs, MD, PhD-candidate Intensive Care Unit / resident cardiology, Catharina Ziekenhuis Eindhoven
    Volume responsiveness mean systemic filling pressure
    Additional relevant MeSH terms:
    Cardiac Output, High

    Study Results

    No Results Posted as of May 19, 2016