Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO
NCT ID: NCT01157299
Last Updated: 2010-07-07
Study Results
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Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2009-09-30
2010-09-30
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Hemodynamic instability
Hypotension and/or evidence of end-organ hypoperfusion
No interventions assigned to this group
Hemodynamic stability
Normotension and end-organ normoperfusion along with
* Vasopressor, vasodilator or inotropic therapy
* Edema and/or evidence of hypervolemia
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient equipped with a femoral arterial catheter and central venous catheter or who requires advanced hemodynamic monitoring
* Parents consent
Exclusion Criteria
* 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
1 Month
18 Years
ALL
No
Sponsors
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Hospital Universitario La Paz
OTHER
Responsible Party
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Hospital Universitario La Paz
Principal Investigators
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Pedro de la Oliva, MD PhD.
Role: STUDY_DIRECTOR
Hospital Universitario La Paz
Ignacio Sánchez-Díaz, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario 12 de Octubre de Madrid
Elena Alvarez-Rojas, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Ramón y Cajal de Madrid
Susana Jaraba-Caballero, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Reina Sofia de Córdoba
Patricia Roselló-Millet, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Universitario de Valencia
José Manuel González-Gómez, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Carlos Haya de Málaga
Ana Serrano-Gonzalez, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Infantil Universitario del Niño Jesús
Eduardo Consuegra-Llapur, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Materno-Infantil de las Palmas de Gran Canaria
Locations
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Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Infantil Universitario del Niño Jesús
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario Carlos Haya
Málaga, , Spain
Hospital Clinico Universitario
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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HULP-PI-800
Identifier Type: -
Identifier Source: org_study_id
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