PPV to Guide Fluid Management in the PICU

NCT02308371 | Completed Results

• 1 other identifier: 14-2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Systemic Inflammatory Response Syndrome

Keywords

critically ill pediatric patients; fluid resuscitation

Outcome Measures

Primary Outcomes (2)

• Total Fluid (ml/kg/Day) Given

  Total fluid (ml/kg/day) given during the first 48 hours of enrollment

  First 48 hours after enrollment

• Total Fluid Bolused

  Total fluid bolused within 48 hours after enrollment.

  48 hours after enrollment

Secondary Outcomes (3)

• Number of Hours on Vasopressors

  From pediatric ICU admission to pediatric ICU discharge (up to 149 days)

• Number of Days on Ventilatory Support

  From pediatric ICU admission to pediatric ICU discharge (up to 149 days)

• Number of Days in the PICU

  From pediatric ICU admission to pediatric ICU discharge (up to 149 days)

Study Arms (2)

Prospective

EXPERIMENTAL

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

Retrospective

NO INTERVENTION

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.

Interventions

Automated Pulse Pressure Variation DEVICE

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.

Also known as: Realtime automated pulse pressure variation algorithm, Philips MX800 monitor

Prospective

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (30)

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  BACKGROUND

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MeSH Terms

Conditions

Sepsis; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Results Point of Contact

• Title: Dr. Melissa Hines
• Organization: University of North Carolina

mhinesthomas@gmail.com

901-652-6138

Study Officials

• Melissa R Hines, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Umesh Joashi, MD

  University of North Carolina

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: December 4, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 2, 2017
• Results First Posted: January 2, 2017

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)