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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
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
Children who are critically ill often require large amounts of fluid during their acute illness. It has been shown in multiple studies that appropriate administration of fluid decreases morbidity and mortality, but giving too much fluid can also cause increased morbidity and mortality. It is often difficult to discern from physical exam, vital signs and labs if the amount of fluid that has been given is appropriate or if a pediatric patient requires more fluid. Pulse pressure variation (PPV) is the change in blood pressure when a patient is on a ventilator or breathing machine. PPV has been used in multiple adult studies to help predict fluid needs in a critically ill patient. In this study, we would like to investigate if PPV can help better predict if critically ill pediatric patients in the pediatric intensive care unit (PICU) need fluid. The investigators hope that by having the additional information that PPV can provide, physicians can more judiciously give fluid and thereby improve morbidity of critically ill patients in the PICU.

Condition or disease Intervention/treatment Phase
Sepsis Systemic Inflammatory Response Syndrome Device: Automated Pulse Pressure Variation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
Experimental: Prospective
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.
Other Names:
  • Realtime automated pulse pressure variation algorithm
  • Philips MX800 monitor

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.



Primary Outcome Measures :
  1. 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

  2. Total Fluid Bolused [ Time Frame: 48 hours after enrollment ]
    Total fluid bolused within 48 hours after enrollment.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Admission to the University of North Carolina pediatric critical care unit, includes all patients admitted to the pediatric critical care service as well as all post-operative patients.
  2. No limitations for age or gender.
  3. Patient requires standard mechanical ventilation.
  4. Patient has an arterial line in place.

Exclusion Criteria:

  1. Patient not mechanically ventilated.
  2. Patient does not have arterial line placed.
  3. Patient requires extracorporeal life support.
  4. Patient requires placement on high frequency oscillatory ventilation.
  5. Pulse pressure variation unable to be obtained on monitor.
  6. Patient has open chest.
  7. Patient has arrhythmias.

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Melissa R Hines, MD University of North Carolina
Study Director: Umesh Joashi, MD University of North Carolina
Publications:
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. Erratum in: Crit Care Med. 2009 Apr;37(4):1536. Skache, Sara [corrected to Kache, Saraswati]; Irazusta, Jose [corrected to Irazuzta, Jose].
Saxena R, Durward A, Puppala NK, et al. A comparison between novel static and dynamic markers of fluid responsiveness: preliminary data from 47 children. Proc 22nd Annu Congr ESPNIC. 2011;37 Suppl 2:S315-442. doi:10.1007/s00134-011-2387-x.

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02308371    
Other Study ID Numbers: 14-2019
First Posted: December 4, 2014    Key Record Dates
Results First Posted: January 2, 2017
Last Update Posted: January 2, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of North Carolina, Chapel Hill:
critically ill pediatric patients
fluid resuscitation
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock