Study S001345

Phase 1-2 Study of the Pharmacology of Exenatide in Pediatric Sepsis

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT01573806
Acronym: PEPS
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1; PHASE2
Masking: QUADRUPLE
Status: WITHDRAWN
Enrollment: 0
Start: 2012-10
Primary completion: 2014-10
Lead sponsor: Seattle Children's Hospital
Conditions: Septic Shock; Inflammation; Glucose Homeostasis; Organ Dysfunction; Health-related Quality of Life
Interventions: DRUG:Exenatide; DRUG:Exenatide vehicle
Results posted: FALSE

Registered primary outcomes

Exenatide associated adverse event occurence [From PICU admission to PICU discharge, an average interval of 7.5 days]
Exenatide pharmacokinetics: Area under the exenatide concentration curve for 4 subcutaneous exenatide injections administered every 12 hours. [48 hours following the first exenatide dose]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0027200	The use of exenatide in severely burned pediatric patients. Mecott GA, Critical care (London, England)	2010	Randomized trial	PMID 20701787 DOI	registry reference BACKGROUND:20701787
R0027086	Pharmacology and tolerability of a single dose of exenatide in adolescent patients with type 2 diabetes mellitus being treated with metformin: a randomized, placebo-controlled, single-blind, dose-escalation, crossover study. Malloy J, Clinical therapeutics	2009	Randomized trial	PMID 19446153 DOI	registry reference BACKGROUND:19446153