N/A
N=100
PPV to Guide Fluid Management in the PICU
Sepsis · Systemic Inflammatory Response Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02308371 ↗Enrolled (actual)
100
Serious AEs
44.0%
Results posted
Jan 2017
Primary outcome: Primary: Total Fluid (ml/kg/Day) Given — 124.38; 122.099 ml/kg/day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Automated Pulse Pressure Variation (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Fluid (ml/kg/Day) Given |
124.38; 122.099 | — |
| PRIMARY Total Fluid Bolused |
11.55; 28.08 | — |
| SECONDARY Number of Hours on Vasopressors |
71.74; 42.4 | — |
| SECONDARY Number of Days on Ventilatory Support |
23.8; 8.68 | — |
| SECONDARY Number of Days in the PICU |
28.66; 12.48 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- No limitations for age or gender.
- Patient requires standard mechanical ventilation.
- Patient has an arterial line in place.
Exclusion Criteria
- Patient not mechanically ventilated.
- Patient does not have arterial line placed.
- Patient requires extracorporeal life support.
- Patient requires placement on high frequency oscillatory ventilation.
- Pulse pressure variation unable to be obtained on monitor.
- Patient has open chest.
- Patient has arrhythmias.
Data sourced from ClinicalTrials.gov (NCT02308371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.