Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO

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Brief Title

Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO

Official Title

Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO

Brief Summary

      The purpose of this study is

        -  To assess the value of dynamics (SVV, PPV) and static indices (GEDVI, ITBVI, CVP) of
           preload and its combination with contractility (CI,SV, ventricular power, dP/dtmax, CFI,
           GEF) and lung water indices (ELWI), as predictors of fluid responsiveness in both
           spontaneously breathing and mechanically ventilated pediatric patients.

        -  To assess the value of stroke volume and pulse pressure changes from femoral pulse
           contour analysis (PiCCO2) during passive leg raising as predictor of fluid
           responsiveness in pediatric patients.

        -  To establish normal and cutoff values of transpulmonary thermodilution (PiCCO2)
           hemodynamic variables in hemodynamically stables and hemodynamically "normal" patients.
    

Detailed Description

      One of the ongoing challenges in critical care has been determining adequate fluid
      resuscitation. Overly aggressive volume expansion may produce deleterious effects, especially
      in patients with respiratory, renal and/or cardiac failure. Since the clinical ability to
      judge hemodynamic parameters is known to be poor, the determination of variables that would
      predict response to fluid challenge would be important for clinical decision-making.

      Traditional measures of preload (CVP, PAOP) are now known to be incapable to assess the
      volume status and fluid responsiveness, especially in children.

      There are two kinds of reasons for explaining the failure of markers of preload to predict
      volume responsiveness: the first reason is that the markers commonly used at the bedside are
      not always accurate measures of cardiac preload; the second reason is that an assessment of
      preload is not an assessment of preload responsiveness.

      The rapid determination of hemodynamic status offered by noninvasive hemodynamic devices as
      PICCO2 would allow tailoring of volume expansion necessary in hypoperfusion states to
      increase left ventricular volume and cardiac output. Studies in critically ill adults
      patients have demonstrated that passive leg raising autotransfusion and functional
      hemodynamic monitoring, by using pulse contour analysis, are reliable in the detection of
      fluid responsiveness. However, currently we have very few studies in pediatric patients using
      arterial pulse contour analysis and transpulmonary thermodilution, which does not allow the
      rational application of the hemodynamic variables for guiding fluid resuscitation.

      This study pretend to assess 1) the value of dynamics and static indices of preload, and its
      combination with contractility and lung water indices, as predictors of fluid responsiveness
      in both spontaneously breathing and mechanically ventilated pediatric patients and 2) the
      value of stroke volume and pulse pressure changes during passive leg raising autotransfusion,
      as predictors of fluid responsiveness in pediatric patients.

      In this observational study, the hemodynamical variables are registered during the
      hemodynamically unstable, stable and "normal" states of the pediatric patient and before and
      after clinically indicated fluid (crystalloid, colloid or hemoderivative) infusion. Passive
      leg raising hemodynamic changes will be compared with the hemodynamic changes caused by fluid
      infusion.
    


Study Type

Observational




Condition

Shock


Study Arms / Comparison Groups

 Hemodynamic instability
Description:  Hypotension and/or evidence of end-organ hypoperfusion

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

100

Start Date

September 2009

Completion Date

September 2010

Primary Completion Date

August 2010

Eligibility Criteria

        Inclusion Criteria:

          -  Pediatric patients admitted to PICU

          -  Patient equipped with a femoral arterial catheter and central venous catheter or who
             requires advanced hemodynamic monitoring

          -  Parents consent

        Exclusion Criteria:

          -  Absolute

               -  Patient with left to right cardiac shunts

               -  Patient with extra-corporeal life support

               -  Less than 4 Kg body weight

          -  For passive leg raising procedure

               -  Patient with head trauma or intracranial hypertension

               -  Patient in prone position

               -  Patient who may not tolerate supine or Trendelenburg position: ej. Glenn
                  procedure

               -  Patient with hip injury
      

Gender

All

Ages

1 Month - 18 Years

Accepts Healthy Volunteers

No

Contacts

Pedro de la Oliva, MD PhD., +34917277149, [email protected]

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT01157299

Organization ID

HULP-PI-800



Study Sponsor

Hospital Universitario La Paz


Study Sponsor

Pedro de la Oliva, MD PhD., Study Director, Hospital Universitario La Paz


Verification Date

June 2010