Trial · Interventional

WithdrawnPhase 1/2Registry data

Pharmacology of Exenatide in Pediatric Sepsis

Short name PEPS

NCTNCT01573806Other idPEPS-SCH-001

Open at ClinicalTrials.govAsk about this trial

This trial was withdrawn before it enrolled anyone.

Reason given at the registry: No funding

Overview

Status: Withdrawn
Phase: Phase 1/2
Enrollment: 0 participants (actual)
Sponsor: Seattle Children's Hospital · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Oct 2012
Primary completion: Oct 2014 (estimated)
Completion: Oct 2014 (estimated)
First posted: 10 Apr 2012 (estimated)
Last update posted: 5 Oct 2017
Conditions: Septic Shock · Inflammation · Glucose Homeostasis · Organ Dysfunction · Health-related Quality of Life

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2012201320142015

Ph 1/2
PEPS
NCT01573806
Oct 2012 to est. Oct 2014
Withdrawn
Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

ExenatideDrug
Exenatide vehicleDrug

Arms2

Active comparator
Exenatide
Subjects dosed with exenatide in Phase 2
Placebo comparator
Exenatide vehicle
Subjects dosed with exenatide vehicle in Phase 2

Primary outcomes2

Outcomes the sponsor listed as primary.

Exenatide associated adverse event occurence
Time frame · From PICU admission to PICU discharge, an average interval of 7.5 days
Registry description
Potential adverse events associated with exenatide: nausea, abdominal pain, hypoglycemia, delayed gastric emptying, pancreatitis, renal dysfunction, reactions at injection site. Adverse event occurence will be tabulated while the subject remains in the PICU.
Exenatide pharmacokinetics: Area under the exenatide concentration curve for 4 subcutaneous exenatide injections administered every 12 hours.
Time frame · 48 hours following the first exenatide dose
Registry description
Delineation of the pharmacokinetics of subcutaneously dosed exenatide among children with de novo septic shock.

Secondary outcomes(8)

Exenatide pharmacodynamics: Effect of exenatide on glucose homeostasis
Time frame · 60 hours following first exenatide dose
Registry description
Delineation of exenatide pharmacodynamics among children with de novo septic shock: AUC of all serum glucose values or results of continuous glucose monitoring obtained during the 60 hours following the first dose of exenatide (or drug vehicle).
Exenatide pharmacodynamics: Effect of exenatide on serum inflammatory cytokine concentrations.
Time frame · 60 hours following first exenatide dose
Registry description
Delineation of exenatide pharmacodynamics among children with de novo septic shock: AUC of serial serum inflammatory cytokine concentrations.
Exenatide clinical efficacy: Effect of exenatide on intensity and duration of organ dysfunctions.
Time frame · From PICU admission to PICU discharge, an average interval of 7.5 days
Registry description
AUC of daily Pediatric Logistic Organ Dysfunction (PELOD) scores while the subject remains in the PICU
Exenatide clinical efficacy: Effect of exenatide on intensity and duration of hemodynamic instability.
Time frame · From onset to discontinuation of vasoactive-inotropic support, an average interval of 4 days
Registry description
AUC of daily Vasoactive-Inotropic Scores while the subject remains on vasoactive-inotropic support.
Exenatide clinical efficacy: Effect of exenatide on intensity and duration of pulmonary failure.
Time frame · From onset to discontinuation of mechanical ventilator support, an average interval of 4.5 days
Registry description
AUC of daily Saturation Indices (\[FiO2\*MAP\]/SpO2)
Exenatide clinical efficacy: Effect of exenatide on intensity and duration of renal failure
Time frame · From PICU admission to PICU discharge, an average interval of 7.5 days
Registry description
AUC of daily RIFLE criteria
Exenatide clinical efficacy: Effect of exenatide on magnitude of sepsis-associated change in functional status.
Time frame · 2 measurements: baseline and PICU discharge, the latter occuring on average at 7.5 days
Registry description
Determination per parent report of declination from baseline to PICU discharge of, Pediatric Overall Performance Category Score and Functional Status Score
Exenatide clinical efficacy: Effect of exenatide on magnitude of sepsis-associated change in health-related quality of life
Time frame · 2 measurements: baseline and PICU discharge, the latter occuring on average at 7.5 days
Registry description
Determination per parent report of declination from baseline to PICU discharge of, Pediatric Quality of Life Inventory, Generic Core Scales, 4.0 (PedsQL)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2010

4 results

The use of exenatide in severely burned pediatric patients.

Mecott et al. 2010Critical care (London, England)cited by 37

PMID 20701787PMC2945137DOI 10.1186/cc9222PUB-20701787

CC BY4 results

Download PDF See results (4)

Indexing hint: Randomized controlled trial · 2009

11 results

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 et al. 2009Clinical therapeuticscited by 29

PMID 19446153DOI 10.1016/j.clinthera.2009.04.005PUB-19446153

Full text at the publisher11 results

Publisher page See results (11)

Eligibility

Who could join, as posted.

Sex: All
Age: from 1 Month up to 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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