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Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness

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ClinicalTrials.gov Identifier: NCT02060942
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : May 19, 2016
Sponsor:
Collaborator:
Erasmus Medical Center
Information provided by (Responsible Party):
L.P.B. Meijs, Catharina Ziekenhuis Eindhoven

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

Condition or disease
Cardiac Output, High

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.

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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 : August 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  1. Heart performance (eH) [ Time Frame: 1 hour ]
    Quotient of driving pressure of venous return in mmHg


Other Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Coronary artery bypass grafting, aortic valve replacement and septic shock patients
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060942


Locations
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Netherlands
Catharina Hospital
Eindhoven, North Brabant, Netherlands, 5623 EJ
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Erasmus Medical Center
Investigators
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Study Chair: Jan Bakker, PhD Erasmus University Hospital Rotterdam The Netherlands

Publications:

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Responsible Party: L.P.B. Meijs, MD, PhD-candidate Intensive Care Unit / resident cardiology, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT02060942     History of Changes
Other Study ID Numbers: M12-1271
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No, data remain anonymized within hospital and property of PI.

Keywords provided by L.P.B. Meijs, Catharina Ziekenhuis Eindhoven:
Volume responsiveness mean systemic filling pressure

Additional relevant MeSH terms:
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Cardiac Output, High
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms