CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Automated Pulse Pressure Variationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02308371
NCT02308371N/ACompleted

Automated Pulse Pressure Variation Guided Fluid Management in the Pediatric Intensive Care Setting

University of North Carolina, Chapel Hill·interventional·Posted Dec 4, 2014·Updated Jan 2, 2017

In Brief

A clinical study evaluating Automated Pulse Pressure Variation for Sepsis and Systemic Inflammatory Response Syndrome. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 4, 2014
Enrollment StartNov 1, 2014
Primary CompletionMay 1, 2016
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.6 years ago

Interventions

Automated Pulse Pressure Variationdevice

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.