Clinical trial NCT01157299: Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO
Official title: Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock
Sepsis
Systemic Inflammatory Response Syndrome
Low Cardiac Output
Dilated Cardiomyopathy
Keywords: Hemodynamics
Pediatric Intensive Care Unit
Low cardiac output
Thermodilution
Stroke volume
Global end-diastolic volume
Fluid responsiveness
Passive leg raising
Infant
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients admitted to the PICU equipped with a femoral arterial catheter and a central venous catheter or who require advanced hemodinamic monitoring

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Infantil Universitario del Niño Jesús
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Valencia
country: Spain
facility: Hospital Clinico Universitario
Study officials:
affiliation: Hospital Universitario La Paz
name: Pedro de la Oliva, MD PhD.
role: STUDY_DIRECTOR
affiliation: Hospital Universitario 12 de Octubre de Madrid
name: Ignacio Sánchez-Díaz, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Ramón y Cajal de Madrid
name: Elena Alvarez-Rojas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Reina Sofia de Córdoba
name: Susana Jaraba-Caballero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario de Valencia
name: Patricia Roselló-Millet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Carlos Haya de Málaga
name: José Manuel González-Gómez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Infantil Universitario del Niño Jesús
name: Ana Serrano-Gonzalez, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Materno-Infantil de las Palmas de Gran Canaria
name: Eduardo Consuegra-Llapur, MD
role: PRINCIPAL_INVESTIGATOR
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