Pharmacokinetic and Biomarker Study of Pioglitazone in Adolescents With Severe Sepsis and Septic Shock
Summary
The purpose of this study is to evaluate the pharmacokinetics of pioglitazone and to determine the effect on inflammatory biomarkers for pioglitazone in patients with severe sepsis and septic shock.
Timeline
- Start
- 2011-10
- Primary completion
- 2016-05
- Completion
- 2017-01
Outcome
Missed primary endpoint
registry analysis (superiority test); Pioglitazone Hydrochloride vs Normal Standard Care; p = 1.0; Wilcoxon (Mann-Whitney) NCT01352182 ↗
registry analysis (superiority test); Pioglitazone Hydrochloride vs Normal Standard Care; p = 0.154; Wilcoxon (Mann-Whitney) NCT01352182 ↗
registry analysis (superiority test); Pioglitazone Hydrochloride vs Normal Standard Care; p = 0.683; Wilcoxon (Mann-Whitney) NCT01352182 ↗
registry analysis (superiority test); Pioglitazone Hydrochloride by Mouth vs Pioglitazone Hydrochloride by Nasogastric Tube; p = 0.08; t-test, 2 sided NCT01352182 ↗
Publications
- Background Kaplan JM, Denenberg A, Monaco M, Nowell M, Wong H, Zingarelli B. Changes in peroxisome proliferator-activated receptor-gamma activity in children with septic shock. Intensive Care Med. 2010 Jan;36(1):123-30. doi: 10.1007/s00134-009-1654-6. Epub 2009 Sep 17.
- Background Sherwin CM, Ding L, Kaplan J, Spigarelli MG, Vinks AA. Optimal study design for pioglitazone in septic pediatric patients. J Pharmacokinet Pharmacodyn. 2011 Aug;38(4):433-47. doi: 10.1007/s10928-011-9202-8. Epub 2011 Jun 11.
- Results Kaplan JM, Zingarelli B, Krallman K, Tang Girdwood S, Lagory D, Mizuno T, Fei L, Wong HR, Vinks AA. Phase 1 safety and pharmacokinetic study on the use of pioglitazone in critically ill patients with sepsis: a randomized clinical trial. Intensive Care Med. 2018 Nov;44(11):2006-2008. doi: 10.1007/s00134-018-5374-7. Epub 2018 Sep 25. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pioglitazone | Small molecule | 0.5 mg/kg | — |