Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome) Clinical Trial
Official title:
Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport
| Verified date | April 2012 |
| Source | University of Arkansas |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
A randomized controlled trial compared the clinical outcomes of transported pediatric patients monitored with an oscillometric blood pressure device versus those monitored with a near-continuous, noninvasive blood pressure.
| Status | Terminated |
| Enrollment | 94 |
| Est. completion date | January 2008 |
| Est. primary completion date | June 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year to 17 Years |
| Eligibility |
Inclusion Criteria: 1. Pediatric patients transported by Angel One to Arkansas Children's Hospital. 2. Age Group: 1 year - 17 years AND 3. Patients at risk of developing SIRS (Systemic Inflammatory Response Syndrome), according to the criteria below. i. The presence of at least two of the following four criteria (one of which must be abnormal temperature or leukocyte count): A. Core temperature of >38.5 C or <36 C. B. Tachycardia, defined as mean heart rate >95th percentile for age in absence of external stimulus, chronic drugs, or painful stimuli. C. Mean respiratory rate >95th percentile for age, or >10% immature neutrophils. OR 4. Patients with moderate or severe head trauma, at risk of developing secondary ischemic brain injury, according to the criteria below. i. Glasgow Coma scale <15 with one or more of the following: A. Mass lesion or cerebral edema on CT or MRI scan. B. Post-Traumatic Seizure. C. Multiple Trauma. D. Focal Neurologic Signs. E. Intubation for control of suspected intracranial hypertension. Exclusion Criteria: 1. Wrist circumference less than 11cm (minimum size for the Vasotrac device). 2. Contractures of the wrists, not allowing correct placement of the Vasotrac device. 3. Hematoma(s) located on both wrists from recent redial (<24hr) artery puncture. 4. Patients likely to proceed to brain death per assessment of the referring physician. 5. Patients being treated for malignant hypertension. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Arkansas Children's Hospital | Little Rock | Arkansas |
| Lead Sponsor | Collaborator |
|---|---|
| University of Arkansas |
United States,
Stroud MH, Prodhan P, Moss M, Fiser R, Schexnayder S, Anand K. Enhanced monitoring improves pediatric transport outcomes: a randomized controlled trial. Pediatrics. 2011 Jan;127(1):42-8. doi: 10.1542/peds.2010-1336. Epub 2010 Dec 20. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care | This is the total number of participants analyzed for the intervention group and the total number of participants analyzed for the control group and the total number of days that each group was analyzed overall. | Up to two weeks | No |
| Secondary | Intensive Care Unit (ICU) Length of Stay | Up to two weeks | No | |
| Secondary | Total Number of Organ Failure Days (Multiple Organ Dysfunction) in the Intensive Care Unit (ICU)for the Control Group and Total Number of Organ Failure Days for the Intervention Group. Multiple Organ Dysfunction is Defined as Multiple Organ Failure. | Total number of organ failure days is for each group as a whole. | Up to two weeks | No |
| Secondary | Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale. | The Therapeutic Intervention Scoring System (TISS-28) is an illness severity score for the ICU. The TISS score can range from zero up to 78. The higher the score is, the more severe the illness. The TISS-28 scale measures the severity of a patient's illness. | Up to two weeks | No |
| Secondary | Amount of Intravenous Fluid Resuscitation | At start of inter-facility transport, then every 15 minutes until arrival. | No |