PPV to Guide Fluid Management in the PICU (PPV)
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|ClinicalTrials.gov Identifier: NCT02308371|
Recruitment Status : Completed
First Posted : December 4, 2014
Results First Posted : January 2, 2017
Last Update Posted : January 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Systemic Inflammatory Response Syndrome||Device: Automated Pulse Pressure Variation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Automated Pulse Pressure Variation Guided Fluid Management in the Pediatric Intensive Care Setting|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||June 2016|
Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5cc/kg increments for PPV> 13 (in addition to standard clinical data) until PPV < 13.
Device: Automated Pulse Pressure Variation
Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours.
No Intervention: Retrospective
Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data. PPV was not used to guide therapy in this group of patients.
- Total Fluid (ml/kg/Day) Given [ Time Frame: First 48 hours after enrollment ]Total fluid (ml/kg/day) given during the first 48 hours of enrollment
- Total Fluid Bolused [ Time Frame: 48 hours after enrollment ]Total fluid bolused within 48 hours after enrollment.
- Number of Hours on Vasopressors [ Time Frame: From pediatric ICU admission to pediatric ICU discharge (up to 149 days) ]Hours that a subject remained intubated during pediatric intensive care admission during subject recruitment
- Number of Days on Ventilatory Support [ Time Frame: From pediatric ICU admission to pediatric ICU discharge (up to 149 days) ]Number of days subject was on ventilatory support (during time of subject enrollment) to the pediatric critical care unit. This included subjects that were intubated or was on a ventilator with a tracheotomy
- Number of Days in the PICU [ Time Frame: From pediatric ICU admission to pediatric ICU discharge (up to 149 days) ]Number of days for admission pediatric critical care unit (admission during which subject was enrolled into the study)
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): NCT02308371
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27514|
|Principal Investigator:||Melissa R Hines, MD||University of North Carolina|
|Study Director:||Umesh Joashi, MD||University of North Carolina|