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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

Tracking Information
First Submitted Date August 23, 2013
First Posted Date February 12, 2014
Last Update Posted Date May 19, 2016
Study Start Date August 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2014)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02060942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 11, 2014)
Heart performance (eH) [ Time Frame: 1 hour ]
Quotient of driving pressure of venous return in mmHg
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 11, 2014)
  • Secondary hemodynamic parameters [ Time Frame: 1 hour ]
    Heart Rate
  • Secondary hemodynamic parameters [ Time Frame: 1 hour ]
    Mean Arterial Blood Pressure
  • Secondary hemodynamic parameters [ Time Frame: 1 hour ]
    Cardiac Index
  • Secondary hemodynamic parameters [ Time Frame: 1 hour ]
    Central Venous Pressure
  • Secondary hemodynamic parameters [ Time Frame: 1 hour ]
    Systemic Vascular Resistance
  • Secondary hemodynamic parameters [ Time Frame: 1 hour ]
    Pulse Pressure Variation
  • Secondary hemodynamic parameters [ Time Frame: 1 hour ]
    Pulmonary Vascular Permeability Index
  • Secondary hemodynamic parameters [ Time Frame: 1 hour ]
    Plethysmographic Oxygen Saturation
  • Secondary hemodynamic parameters [ Time Frame: 1 hour ]
    Delivery of Oxygen Index
  • Secondary hemodynamic parameters [ Time Frame: 1 hour ]
    Mechanical Ventilation Settings
  • Secondary hemodynamic parameters [ Time Frame: 1 hour ]
    End-tidal CO2
  • Secondary hemodynamic parameters [ Time Frame: 1 hour ]
    Peripheral Temperature
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness
Official Title Mean Systemic Filling Pressure and Heart Performance as Predictors of Successful Fluid Responsiveness in Patients With Coronary Artery Bypass Grafting
Brief Summary Determining 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Coronary artery bypass grafting, aortic valve replacement and septic shock patients
Condition Cardiac Output, High
Intervention Not Provided
Study Groups/Cohorts 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 18, 2016)
40
Original Estimated Enrollment
 (submitted: February 11, 2014)
60
Actual Study Completion Date January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02060942
Other Study ID Numbers M12-1271
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No, data remain anonymized within hospital and property of PI.
Responsible Party L.P.B. Meijs, Catharina Ziekenhuis Eindhoven
Study Sponsor Catharina Ziekenhuis Eindhoven
Collaborators Erasmus Medical Center
Investigators
Study Chair: Jan Bakker, PhD Erasmus University Hospital Rotterdam The Netherlands
PRS Account Catharina Ziekenhuis Eindhoven
Verification Date May 2016