Ignite Creation Date:
2024-05-05 @ 10:39 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01157299
Status:
UNKNOWN
Last Update Posted:
2010-07-07
First Post:
2010-07-06
Brief Title:
Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO
Sponsor:
Hospital Universitario La Paz
Organization:
Hospital Universitario La Paz
Study Overview
Official Title:
Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO
Status:
UNKNOWN
Status Verified Date:
2010-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PreloaDren
Brief Summary:
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 CISV ventricular power dPdtmax 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
To assess the value of dynamics SVV PPV and static indices GEDVI ITBVI CVP of preload and its combination with contractility CISV ventricular power dPdtmax 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
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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None