Clinical trial NCT01048996: Genetic Variability and Biomarkers in Children With Acute Lung Injury
Official title: Genetic Variability and Biomarkers in Children With Acute Lung Injury
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Respiratory Distress Syndrome
Acute Lung Injury
Keywords: Acute Lung Injury
Acute Respiratory Distress Syndrome
Genetic Variability
Plasma Biomarkers
Pediatrics
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: UCSF Benioff Children's Hospital Oakland
name: University of California, San Francisco
First posted: 2010-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited concurrently with subjects recruited for the "RESTORE" sedation study. All patients who have been admited to a Pediatric Intensive/Critical Care Unit and on mechanical ventilation will be screened for eligibility at the participating institutions.

Brief summary: Acute Lung Injury (ALI) and the more severe Acute Respiratory Distress Syndrome (ARDS) are a significant problem in Pediatric Intensive Care Units, affecting up to 16 of every 1000 children admitted to these units. These disorders carry with them high mortality rates as well as numerous long-term effects for the surviving children. As the effects of these diseases have significant social and economic ramifications for affected children and their families, research on the development of ALI/ARDS could significantly change how physicians understand the disease and treat patients.

There are a wide range of problems which make certain PICU patients more likely to develop either ALI or ARDS. This research aims to determine which of these children are at the greatest risk for ALI/ARDS by examining differences in plasma biomarkers and in DNA of a large number of PICU patients. We are hypothesizing that significant differences in the level of specific plasma biomarkers or in the frequency of specific DNA variants exist in children who develop ALI/ARDS.


Eligibility criteria: Inclusion Criteria:

* Consecutive intubated pediatric patients (≥ 2 weeks of age and ≥ 42 weeks corrected gestational age and ≤ 18 years of age) supported on mechanical ventilation for acute pulmonary parenchymal disease enrolled in the RESTORE study.

Exclusion Criteria:

* Intubated and mechanically ventilated for immediate post-operative care and stabilization
* Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
* History of single ventricle at any stage of repair
* Congenital diaphragmatic hernia or paralysis
* Primary pulmonary hypertension
* Critical airway (e.g., post laryngotracheal construction) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
* Ventilator dependent (including noninvasive) on PICU admission (chronic assisted ventilation)
* Neuromuscular respiratory failure
* Spinal cord injury above the lumbar region
* Pain managed by patient controlled analgesia (PCA) or epidural catheter
* Family/medical team has decided not to provide full support (patient treatment considered futile)
* Enrolled in any other sedation clinical trial concurrently or within the last 30 days
* Known allergy to any of the study medications

Primary outcomes:
measure: Development of ALI or ARDS
timeFrame: During PICU stay
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Michael Quasney, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: