Status:
COMPLETED
Gluconeogenesis Rates and Its Precursors in Pediatric Sepsis
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
University of Texas
Conditions:
Sepsis
Hyperglycemia
Eligibility:
All Genders
5-19 years
Brief Summary
Critically ill children have abnormal utilization of nutrients such as glucose, lipids and protein. Often sick children have increased glucose concentrations in blood. However, the origin of the high ...
Detailed Description
This is an observational study, aimed at exploring: i) gluconeogenesis rates ii) sources of gluconeogenesis and pyruvate cycling, and iii) protein kinetics in critically ill children and adolescents,...
Eligibility Criteria
Inclusion
- Septic Pediatric Patients:
- Children age 5-19 years.
- Diagnosis of severe sepsis diagnosed as clinical sepsis syndrome (requires two of the following criteria):
- Source of infection
- Fever or Hypothermia
- Leukocytosis or Leucopenia
- Poor organ perfusion (such as delayed capillary refill or decreased urine output or hypotension)
- Bacteremic sepsis demonstrated by positive blood culture
- Indwelling central and/or arterial venous access as per clinical indication.
Exclusion
- Patients with metabolic diseases (i.e.: urea cycle disorders, cystinuria, Insulin dependent diabetes mellitus, etc.).
- Pregnancy.
- Primary liver failure.
- Healthy Children:
- Inclusion Criteria:
- Age 13-19 years.
- Evidence of health as assessed by physical exam, and laboratory tests, including: Hematocrit no less than 36% for males and no less than 37% for females, white blood cell count from 5-10,000.
- Chemistries within normal range, normal urine analysis, and fasting plasma glucose level no less than 60 or greater than 104 mg/dL.
- Lean Children with BMI of 18-24.
- Obese Children with BMI of 30 or greater.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01890928
Start Date
March 1 2011
End Date
October 1 2013
Last Update
April 28 2016
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390