Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO (PreloaDren)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Hospital Universitario La Paz.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT01157299
First received: July 6, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.

Condition
Shock
Sepsis
Systemic Inflammatory Response Syndrome
Low Cardiac Output
Dilated Cardiomyopathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO

Resource links provided by NLM:


Further study details as provided by Hospital Universitario La Paz:

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hemodynamic instability
Hypotension and/or evidence of end-organ hypoperfusion
Hemodynamic stability

Normotension and end-organ normoperfusion along with

  • Vasopressor, vasodilator or inotropic therapy
  • Edema and/or evidence of hypervolemia
Hemodinamically "normal"

Normotension and end-organ normoperfusion along with

  • Non vasopressor, vasodilator or inotropic therapy
  • Normohydration state
  • Non Systemic Inflammatory Response Syndrome
  • Spontaneous breathing and PEEP, or CPAP, equal or less than 5 cm H2O

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

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157299

Contacts
Contact: Pedro de la Oliva, MD PhD +34917277149 poliva.hulp@salud.madrid.org

Locations
Spain
Hospital Universitario Reina Sofia Recruiting
Cordoba, Spain, 14004
Contact: Susana Jaraba-Caballero, MD       sjaraba@gmail.com   
Principal Investigator: Susana Jaraba-Caballero, MD         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28223
Contact: Pedro de la Oliva, MD PhD    +34917277149    poliva.hulp@salud.madrid.org   
Contact: Juan Jose Fernandez-Suso, MD    +34917277149    juanjomen@yahoo.es   
Principal Investigator: Pedro de la Oliva, MD PhD         
Sub-Investigator: Juan Jose Menéndez-Suso, MD         
Sub-Investigator: Cristina Schuffelmann, MD         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Ignacio Sanchez-Diaz, MD PhD       jsanchezd.hdoc@salud.madrid.org   
Principal Investigator: Ignacio Sanchez-Diaz, MD PhD         
Sub-Investigator: Silvia Belda-Hofheinz, MD         
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Maria Elena Alvarez-Rojas, MD       alvarojas@hotmail.com   
Principal Investigator: Maria Elena Alvarez-Rojas, MD         
Hospital Infantil Universitario del Niño Jesús Recruiting
Madrid, Spain, 28009
Contact: Ana Serrano, MD PhD       aserrano.hnjs@salud.madrid.org   
Principal Investigator: Ana Serrano, MD PhD         
Sub-Investigator: Maria Isabel Iglesias-Bouzas, MD         
Hospital Regional Universitario Carlos Haya Recruiting
Malaga, Spain, 29010
Contact: Jose Manuel Gonzalez-Gomez, MD       josemagogo@hotmail.com   
Principal Investigator: Jose Manuel Gonzalez-Gomez, MD         
Hospital Clinico Universitario Recruiting
Valencia, Spain, 46010
Contact: Patricia Roselló-Millet, MD       rosello_pat@gva.es   
Principal Investigator: Patricia Roselló-Millet, MD         
Sponsors and Collaborators
Hospital Universitario La Paz
Investigators
Study Director: Pedro de la Oliva, MD PhD. Hospital Universitario La Paz
Principal Investigator: Ignacio Sánchez-Díaz, MD PhD Hospital Universitario 12 de Octubre de Madrid
Principal Investigator: Elena Alvarez-Rojas, MD Hospital Universitario Ramón y Cajal de Madrid
Principal Investigator: Susana Jaraba-Caballero, MD Hospital Universitario Reina Sofia de Córdoba
Principal Investigator: Patricia Roselló-Millet, MD University of Valencia
Principal Investigator: José Manuel González-Gómez, MD Hospital Universitario Carlos Haya de Málaga
Principal Investigator: Ana Serrano-Gonzalez, MD PhD Hospital Infantil Universitario del Niño Jesús
Principal Investigator: Eduardo Consuegra-Llapur, MD Hospital Universitario Materno-Infantil de las Palmas de Gran Canaria
  More Information

Publications:
Brierley J, Carcillo JA, Choong K, Cornell T, Decaen A, Deymann A, Doctor A, Davis A, Duff J, Dugas MA, Duncan A, Evans B, Feldman J, Felmet K, Fisher G, Frankel L, Jeffries H, Greenwald B, Gutierrez J, Hall M, Han YY, Hanson J, Hazelzet J, Hernan L, Kiff J, Kissoon N, Kon A, Irazuzta J, Lin J, Lorts A, Mariscalco M, Mehta R, Nadel S, Nguyen T, Nicholson C, Peters M, Okhuysen-Cawley R, Poulton T, Relves M, Rodriguez A, Rozenfeld R, Schnitzler E, Shanley T, Kache S, Skippen P, Torres A, von Dessauer B, Weingarten J, Yeh T, Zaritsky A, Stojadinovic B, Zimmerman J, Zuckerberg A. Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med. 2009 Feb;37(2):666-88. Erratum in: Crit Care Med. 2009 Apr;37(4):1536. Skache, Sara [corrected to Kache, Saraswati]; Irazusta, Jose [corrected to Irazuzta, Jose].

Responsible Party: Pedro de la Oliva, Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01157299     History of Changes
Other Study ID Numbers: HULP-PI-800
Study First Received: July 6, 2010
Last Updated: July 6, 2010
Health Authority: Spain: Ethics Committee
Spain: Ministry of Health and Consumption

Keywords provided by Hospital Universitario La Paz:
Hemodynamics
Pediatric Intensive Care Unit
Low cardiac output
Thermodilution
Stroke volume
Global end-diastolic volume
Fluid responsiveness
Passive leg raising
Infant

Additional relevant MeSH terms:
Cardiac Output, Low
Cardiomyopathy, Dilated
Sepsis
Shock
Systemic Inflammatory Response Syndrome
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Cardiomegaly
Infection
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014