NCT01157299|UnknownDMC
Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO
PreloaDren
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PreloaDren
Sponsor study identifier
observational
100
1 country
7
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
July 6, 2010
Actual (reported)July 7, 2010
Actual (reported)August 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Hypotension and/or evidence of end-organ hypoperfusion
Normotension and end-organ normoperfusion along with * Vasopressor, vasodilator or inotropic therapy * Edema and/or evidence of hypervolemia
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
Pediatric patients admitted to the PICU equipped with a femoral arterial catheter and a central venous catheter or who require advanced hemodinamic monitoring
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Infantil Universitario del Niño Jesús
Madrid, 28009, Spain
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.
Pedro de la Oliva, MD PhD.
Hospital Universitario La Paz
Ignacio Sánchez-Díaz, MD PhD
Hospital Universitario 12 de Octubre de Madrid
Elena Alvarez-Rojas, MD
Hospital Universitario Ramón y Cajal de Madrid
Susana Jaraba-Caballero, MD
Hospital Universitario Reina Sofia de Córdoba
First Submitted
July 6, 2010
First Posted
July 7, 2010
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Estimated (date passed)Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness
Contact the study team to confirm eligibility.
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28223, Spain
Hospital Regional Universitario Carlos Haya
Málaga, 29010, Spain
Hospital Clinico Universitario
Valencia, 46010, Spain
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.
Patricia Roselló-Millet, MD
Hospital Clínico Universitario de Valencia
José Manuel González-Gómez, MD
Hospital Universitario Carlos Haya de Málaga
Ana Serrano-Gonzalez, MD PhD
Hospital Infantil Universitario del Niño Jesús
Eduardo Consuegra-Llapur, MD
Hospital Universitario Materno-Infantil de las Palmas de Gran Canaria
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 7, 2010
Record last verified: 2010-06
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