Trial document




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  DRKS00005582

Trial Description

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Title

Prospective, single-center, open clinical trial to compare two non-calibrated systems for the continuous measurement of cardiac output and stroke volume variation (LiDCO rapid®, ICON®) with a calibrated system using Thermodilutionin (PiCCO®) in adult cardiac surgical patients.

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Trial Acronym

Hemodynamic Study 1

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URL of the Trial

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Brief Summary in Lay Language

The monitoring of cardiovascular function during cardiac surgery has hitherto been usually using special methods such as a continuous electrocardiogram (ECG, graphical representation of the variation of electrical phenomena which accompany the cardiac activity ), a blood pressure measurement directly in the artery or alternatively with the so-called PiCCO® - (Pulse contur cardiac Output (determination of cardiac output (the volume of blood being pumped by the heart in one minute on the main artery in the bloodstream) by pulse contour analysis)) technology. In this method, through a central venous catheter ((CVC ) thin plastic tube that is inserted through a vein of the upper half of the body into the venous system and its end in the upper or lower vena cava before the right atrium of the heart) a cold sodium chloride solution is injected into the right atrium of the heart. This fluid bolus flowing through the blood stream into the right ventricle through the pulmonary circulation into the left atrium , left ventricle, and is then distributed through the arteries throughout the body. Using a arterial placed temperature sensor the time course of the decrease of the blood temperature is then detected and calculates into the cardiac output. This method is used in our study as a comparison method.
By using the measurement methods to be tested in our study (LiDCO rapid® , ICON®) the monitoring may be with fewer complications, faster and are thus less done distressing for patients. Reasons for this include the lack of need for a central venous catheterization and the risks and complications associated as well as the different approach to the investment of the arterial cannula.
From the implementation of the planned investigation, we hope to shed light on whether these less expensive and less invasive procedures (LiDCO rapid® , ICON®) allow a reliable monitoring of the patient as the current gold standard (PiCCO®). Through the use of LiDCO rapid® and ICON® the monitoring of cardiovascular functions may be performed faster, less invasive, with fewer complications and therefore less stressful for the patient .

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Brief Summary in Scientific Language

Both hypo- and hypervolemia can lead to circulatory instability and organ dysfunction and thus increase the complication and mortality rate during and after major surgery, but also in intensive care patients. A balanced perioperative fluid management with the aim of intravascular normovolemia and an adequate oxygen supply, therefore, improves the outcome. In contrast to measurements such as heart rate, blood pressure, central venous pressure, the SVV and the PPV are valid parameters for the prediction of fluid responsiveness. With the passive lifting of the legs before volume administration a test (passive leg raising test, PLRT) is available, with which the response to the volume load should be tested reversible. The aim of our investigation is to find out whether the SVV and the PPV determined by the LIDCOrapid® can be used for accurate prediction of the fluid responsiveness, as determined by means PiCCO®. Furthermore, we tested the PLRT on its reliability.
After approval by the Ethics Committee the postoperative fluid management in 50 cardiac surgical intensive care patients is controlled both by the LIDCOrapid® and the ICON® as well as with the PiCCO® system to determine if the non-calibrated methods (LiDCOrapid®, ICON®) can measure the cardiac output, the systemic resistance and the SVV as valid and accurately as it is determined with the PiCCO® system (validation of the tested intervention) and whether the changes of SVV and PPV during the PLRT are good to predict fluid responsiveness (SVV and PPV as predictors of fluid responsiveness). In addition, we will investigate whether the changes in SVV (PiCCO® , LiDCOrapid®, ICON® ) and PPV (LiDCOrapid®) during the PLRT are more or less suitable for the prediction of volume responsiveness of a patient, as the changes in arterial blood pressure during the PLRT and whether during the PLRT optionally observable decrease in the SVV and the PPV is adapted to estimate the volume which is required to cause a similar cycle reaction.
The LiDCOrapid®, which requires only an arterial vascular access and the ICON® that measures via adhesive electrodes would then be suitable for perioperative monitoring of patients and could replaced the much more expensive to install PiCCO® system in certain situations or extend the otherwise common hemodynamic monitoring (arterial blood pressure, CVP, etc.) to the parameters mentioned above.

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Organizational Data

  •   DRKS00005582
  •   2014/01/14
  •   [---]*
  •   yes
  •   Approved
  •   2012051, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

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Health Condition or Problem studied

  •   I97 -  Postprocedural disorders of circulatory system, not elsewhere classified
  •   Diseases that make a determination of cardiac output and stroke volume variation necessary
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Interventions/Observational Groups

  •   Parallel testing LiDCO rapid® vs. ICON® vs. PiCCO®
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Sensitivity and specificity obtained with the LiDCO rapid®, the PiCCO® and the ICON® apparatus parameters stroke volume variation (SVV) and pulse pressure variation (PPV) (excluding LiDCO rapid®) for the prediction of fluid responsiveness (change in cardiac output by ≥ 10% by volume rendering) at different tidal volume (validation SVV, PPV)

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Secondary Outcome

• Sensitivity and specificity of the clinical "Passive Leg Raising test" to predict fluid responsiveness (same direction changes of cardiac output by ≥ 10% after PLRT and volume administration) at different tidal volume (validation PLRT).
• difference between the LiDCO rapid® and the ICON® determined hemodynamic parameters cardiac output (CO), stroke volume variation (SVV) and pulse pressure variation (PPV) (excluding LiDCO rapid®) and measured by PiCCO® values ​​(validation LiDCO rapid® and ICON® vs. PiCCO®) calibrated taking into account the repetition accuracy of PiCCO® measurement method (PiCCO® vs. PiCCO® not calibrated) at different tidal volumes.
• extent and direction of changes in the cardiac output associated with the highest sensitivity and specificity to changes in the parameters of fluid responsiveness (SVV, PPV).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/06/15
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   88   Years
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Additional Inclusion Criteria

• Planned determination of cardiac output (CO) and stroke volume variation (SVV) by a monitoring procedure in adult cardiac surgical patients.
• Written consent of the patient.

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Exclusion Criteria

• Absolute arrhythmia.
• Spontaneous breathing.
• ASA> 4
• infections or skin diseases in the area of possible puncture sites.
• Participation in another interventional clinical trials.
• diseases or disorders that makes the participation in this clinical trial not possible in the opinion of the investigator (support systems in operation (IABP, MECC), hemodynamic instability, catecholamine therapy).

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Addresses

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    • Klinik für Anästhesiologie, operative Intensivmedizin und SchmerztherapieHelios Klinikum Krefeld
    • Mr.  Dr. med.  Patrick  Braß 
    • Lutherplatz 40
    • 47800  Krefeld
    • Germany
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    • Klinik für Anästhesiologie, operative Intensivmedizin und SchmerztherapieHelios Klinikum Krefeld
    • Mr.  Dr. med.  Patrick  Braß 
    • Lutherplatz 40
    • 47800  Krefeld
    • Germany
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    • Klinik für Anästhesiologie, operative Intensivmedizin und SchmerztherapieHelios Klinikum Krefeld
    • Mr.  Dr. med.  Patrick  Braß 
    • Lutherplatz 40
    • 47800  Krefeld
    • Germany
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Sources of Monetary or Material Support

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    • Helios Klinikum Krefeld
    • Lutherplatz 40
    • 47800  Krefeld
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/11/28
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.