Pharmacology of Exenatide in Pediatric Sepsis

• Status: Withdrawn
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Pharmacology of Exenatide in Pediatric Sepsis, PEPS is a phase 1-2 research study that will examine drug safety, drug metabolism, drug action and preliminary drug clinical effects of four does of exenatide injected every 12 hours to children with shock from infection (septic shock). The investigators hypothesize that exenatide can be safely dosed to children with sepsis to achieve blood levels of drug similar to that achieved in teenagers with type 2 diabetes. The investigators further hypothesize that injection of exenatide to children with septic shock will normalize blood glucose levels and decrease levels of inflammation proteins in the blood during the early course of sepsis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Children's Hospital
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• Age 44 weeks estimated gestational age to 18 years AND

• Admitted to the PICU for the sepsis event AND

• Vascular catheter capable of providing serial blood samples in place AND

• Diagnosis of septic shock = sepsis with cardiovascular organ dysfunction AND

• Parents speak English or Spanish

Exclusion Criteria:

• Greater than 12 hours from admission to PICU to enrollment OR

• Chronic or acute dialytic therapy, history of renal impairment or renal transplantation OR

• History of pancreatitis OR

• History of hypersensitivity to Byetta OR

• History of severe gastrointestinal disease or gastroparesis OR

• History of diabetes mellitus, type I or type II OR

• History of insulin, sulfonyl urea drugs, or coumarin use OR

• History of hypoglycemia OR

• History of active pregnancy (effect of exenatide on the fetus is unknown) OR

• Inability to collect serial blood samples OR

• Previously enrolled in the PEPS study OR

• Lack of commitment to aggressive sepsis therapy OR

• Expectation to succumb from the sepsis event OR

• Patient is a foster child and/or ward of the state OR

• Sepsis event associated with a PICU-acquired nosocomial infection OR

• Patient is enrolled in another interventional investigation that might obscure the potential effects of exenatide dosing.