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

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Systemic Inflammatory Response Syndrome; Shock; Dilated Cardiomyopathy; Low Cardiac Output

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
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Spain
  • Cordoba, Spain, 14004
    • Recruiting
    • Hospital Universitario Reina Sofia
    • Contact: Susana Jaraba-Caballero, MD; Email: sjaraba@gmail.com
    • Principal Investigator: Susana Jaraba-Caballero, MD
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon y Cajal
    • Contact: Maria Elena Alvarez-Rojas, MD; Email: alvarojas@hotmail.com
    • Principal Investigator: Maria Elena Alvarez-Rojas, MD
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
    • Contact: Ignacio Sanchez-Diaz, MD PhD; Email: jsanchezd.hdoc@salud.madrid.org
    • Principal Investigator: Ignacio Sanchez-Diaz, MD PhD
    • Sub-Investigator: Silvia Belda-Hofheinz, MD
  • Madrid, Spain, 28009
    • Recruiting
    • Hospital Infantil Universitario del Niño Jesús
    • Contact: Ana Serrano, MD PhD; Email: aserrano.hnjs@salud.madrid.org
    • Principal Investigator: Ana Serrano, MD PhD
    • Sub-Investigator: Maria Isabel Iglesias-Bouzas, MD
  • Madrid, Spain, 28223
    • Recruiting
    • Hospital Universitario La Paz
    • Contact: Pedro de la Oliva, MD PhD; Phone Number: +34917277149; Email: poliva.hulp@salud.madrid.org
    • Contact: Juan Jose Fernandez-Suso, MD; Phone Number: +34917277149; Email: juanjomen@yahoo.es
    • Sub-Investigator: Juan Jose Menéndez-Suso, MD
  • Malaga, Spain, 29010
    • Recruiting
    • Hospital Regional Universitario Carlos Haya
    • Contact: Jose Manuel Gonzalez-Gomez, MD; Email: josemagogo@hotmail.com
    • Principal Investigator: Jose Manuel Gonzalez-Gomez, MD
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clínico Universitario
    • Contact: Patricia Roselló-Millet, MD; Email: rosello_pat@gva.es
    • Principal Investigator: Patricia Roselló-Millet, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

• Sponsor: 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 Sofía de Córdoba; Principal Investigator: Patricia Roselló-Millet, MD, Hospital Clinico Universitario de 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

Publications and helpful links

General Publications

• Slater A, Shann F, Pearson G; Paediatric Index of Mortality (PIM) Study Group. PIM2: a revised version of the Paediatric Index of Mortality. Intensive Care Med. 2003 Feb;29(2):278-85. doi: 10.1007/s00134-002-1601-2. Epub 2003 Jan 23.
• Durand P, Chevret L, Essouri S, Haas V, Devictor D. Respiratory variations in aortic blood flow predict fluid responsiveness in ventilated children. Intensive Care Med. 2008 May;34(5):888-94. doi: 10.1007/s00134-008-1021-z. Epub 2008 Feb 8.
• 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. doi: 10.1097/CCM.0b013e31819323c6. Erratum In: Crit Care Med. 2009 Apr;37(4):1536. Skache, Sara [corrected to Kache, Saraswati]; Irazusta, Jose [corrected to Irazuzta, Jose].
• Michard F, Descorps-Declere A, Lopes MR. Using pulse pressure variation in patients with acute respiratory distress syndrome. Crit Care Med. 2008 Oct;36(10):2946-8. doi: 10.1097/CCM.0b013e318187b6fd. No abstract available.
• Osman D, Ridel C, Ray P, Monnet X, Anguel N, Richard C, Teboul JL. Cardiac filling pressures are not appropriate to predict hemodynamic response to volume challenge. Crit Care Med. 2007 Jan;35(1):64-8. doi: 10.1097/01.CCM.0000249851.94101.4F.
• Lichtwarck-Aschoff M, Zeravik J, Pfeiffer UJ. Intrathoracic blood volume accurately reflects circulatory volume status in critically ill patients with mechanical ventilation. Intensive Care Med. 1992;18(3):142-7. doi: 10.1007/BF01709237.
• Michard F, Alaya S, Zarka V, Bahloul M, Richard C, Teboul JL. Global end-diastolic volume as an indicator of cardiac preload in patients with septic shock. Chest. 2003 Nov;124(5):1900-8. doi: 10.1378/chest.124.5.1900.
• Teboul JL, Monnet X. Prediction of volume responsiveness in critically ill patients with spontaneous breathing activity. Curr Opin Crit Care. 2008 Jun;14(3):334-9. doi: 10.1097/MCC.0b013e3282fd6e1e.
• Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.
• Heenen S, De Backer D, Vincent JL. How can the response to volume expansion in patients with spontaneous respiratory movements be predicted? Crit Care. 2006;10(4):R102. doi: 10.1186/cc4970.
• Kim HK, Pinsky MR. Effect of tidal volume, sampling duration, and cardiac contractility on pulse pressure and stroke volume variation during positive-pressure ventilation. Crit Care Med. 2008 Oct;36(10):2858-62. doi: 10.1097/CCM.0b013e3181865aea.
• Pinsky MR. Heart-lung interactions. Curr Opin Crit Care. 2007 Oct;13(5):528-31. doi: 10.1097/MCC.0b013e3282efad97.
• Cecchetti C, Stoppa F, Vanacore N, Barbieri MA, Raucci U, Pasotti E, Tomasello C, Marano M, Pirozzi N. Monitoring of intrathoracic volemia and cardiac output in critically ill children. Minerva Anestesiol. 2003 Dec;69(12):907-18. English, Italian.
• Cecchetti C, Lubrano R, Cristaldi S, Stoppa F, Barbieri MA, Elli M, Masciangelo R, Perrotta D, Travasso E, Raggi C, Marano M, Pirozzi N. Relationship between global end-diastolic volume and cardiac output in critically ill infants and children. Crit Care Med. 2008 Mar;36(3):928-32. doi: 10.1097/CCM.0B013E31816536F7.
• Haque IU, Zaritsky AL. Analysis of the evidence for the lower limit of systolic and mean arterial pressure in children. Pediatr Crit Care Med. 2007 Mar;8(2):138-44. doi: 10.1097/01.PCC.0000257039.32593.DC.
• Brierley J, Peters MJ. Distinct hemodynamic patterns of septic shock at presentation to pediatric intensive care. Pediatrics. 2008 Oct;122(4):752-9. doi: 10.1542/peds.2007-1979.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ANTICIPATED): August 1, 2010
• Study Completion (ANTICIPATED): September 1, 2010

Study Registration Dates

• First Submitted: July 6, 2010
• First Submitted That Met QC Criteria: July 6, 2010
• First Posted (ESTIMATE): July 7, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 7, 2010
• Last Update Submitted That Met QC Criteria: July 6, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Infant; Fluid responsiveness; Hemodynamics; Thermodilution; Low cardiac output; Pediatric Intensive Care Unit; Passive leg raising; Stroke volume; Global end-diastolic volume
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Inflammation; Genetic Diseases, Inborn; Shock; Cardiomegaly; Laminopathies; Cardiomyopathies; Cardiomyopathy, Dilated; Systemic Inflammatory Response Syndrome; Cardiac Output, Low
• Other Study ID Numbers: HULP-PI-800