Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO (PreloaDren)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01157299|
Recruitment Status : Unknown
Verified June 2010 by Hospital Universitario La Paz.
Recruitment status was: Recruiting
First Posted : July 7, 2010
Last Update Posted : July 7, 2010
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 or disease|
|Shock Sepsis Systemic Inflammatory Response Syndrome Low Cardiac Output Dilated Cardiomyopathy|
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|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Official Title:||Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||August 2010|
|Estimated Study Completion Date :||September 2010|
Hypotension and/or evidence of end-organ hypoperfusion
Normotension and end-organ normoperfusion along with
Normotension and end-organ normoperfusion along with
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157299
|Contact: Pedro de la Oliva, MD PhDfirstname.lastname@example.org|
|Hospital Universitario Reina Sofia||Recruiting|
|Cordoba, Spain, 14004|
|Contact: Susana Jaraba-Caballero, MD email@example.com|
|Principal Investigator: Susana Jaraba-Caballero, MD|
|Hospital Infantil Universitario del Niño Jesús||Recruiting|
|Madrid, Spain, 28009|
|Contact: Ana Serrano, MD PhD firstname.lastname@example.org|
|Principal Investigator: Ana Serrano, MD PhD|
|Sub-Investigator: Maria Isabel Iglesias-Bouzas, MD|
|Hospital Universitario Ramón y Cajal||Recruiting|
|Madrid, Spain, 28034|
|Contact: Maria Elena Alvarez-Rojas, MD email@example.com|
|Principal Investigator: Maria Elena Alvarez-Rojas, MD|
|Hospital Universitario 12 de Octubre||Recruiting|
|Madrid, Spain, 28041|
|Contact: Ignacio Sanchez-Diaz, MD PhD firstname.lastname@example.org|
|Principal Investigator: Ignacio Sanchez-Diaz, MD PhD|
|Sub-Investigator: Silvia Belda-Hofheinz, MD|
|Hospital Universitario La Paz||Recruiting|
|Madrid, Spain, 28223|
|Contact: Pedro de la Oliva, MD PhD +34917277149 email@example.com|
|Contact: Juan Jose Fernandez-Suso, MD +34917277149 firstname.lastname@example.org|
|Principal Investigator: Pedro de la Oliva, MD PhD|
|Sub-Investigator: Juan Jose Menéndez-Suso, MD|
|Sub-Investigator: Cristina Schuffelmann, MD|
|Hospital Regional Universitario Carlos Haya||Recruiting|
|Malaga, Spain, 29010|
|Contact: Jose Manuel Gonzalez-Gomez, MD email@example.com|
|Principal Investigator: Jose Manuel Gonzalez-Gomez, MD|
|Hospital Clinico Universitario||Recruiting|
|Valencia, Spain, 46010|
|Contact: Patricia Roselló-Millet, MD firstname.lastname@example.org|
|Principal Investigator: Patricia Roselló-Millet, MD|
|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||Hospital Clínico 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|