NCT01890928

Gluconeogenesis Rates and Its Precursors in Pediatric Sepsis

Gluconeogenesis Rates and Its Source in Critically Ill Adolescents

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 5 Years – 19 Years
• Healthy volunteers: Accepted

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 glucose has not been determined in these populations. There is a close interrelationship between protein and energy metabolism. An increase in the energy supply will not promote nitrogen retention unless the amino acid supply is adequate, and conversely, an increased amino acid supply will be useless if energy is limiting, hence the importance of adequate protein and energy intake. Our study aims to investigate the protein-energy interactions in critically ill septic children and adolescents with the objective to eventually provide the best nutritional support for these patients.

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, and its differences by age group, as well as in comparison to healthy adolescents. The study size will include 45 critically ill septic, pediatric patients (22 children at 5-12 years of age and 23 adolescents' at 13-19 years of age), male and females admitted to the pediatric intensive care unit (PICU) at Children's Medical Center, Dallas. The minimal subject's weight will be 17kg. Additionally, 30 healthy adolescents matched by age, gender, BMI and Tanner stage will be studied at the Clinical Translational Research Center at Zale Lipshy Hospital, to serve as healthy adolescent controls. The number of subjects includes an expected drop out rate of about 20%, in order to obtain 18 patients with complete data in each group. Patients will receive nutritional support as per standard care. This study will yield important knowledge and may lead in the future to changes in the current practice on the management of critically ill pediatric patients in the PICU.

Conditions

• Sepsis
• Hyperglycemia
• Critical Illness

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-07-02
• Last updated: 2016-04-28

Locations

1 site across 1 country: United States