Pharmacokinetic Characteristics of Pioglitazone and Preliminary Biomarker Response in Adolescents Aged 12 to 17 Years With Severe Sepsis and Septic Shock
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evaluate the Safety Profile of Pioglitazone in Patients With Severe Sepsis and Septic Shock as the Number of Hypoglycemic Events
研究概览
简要总结
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.
详细描述
Severe sepsis is a major cause of morbidity and mortality among adults and children. Few clinical trials have demonstrated clinical benefit in sepsis. Severe sepsis is a systemic inflammatory syndrome in response to infection that is associated with acute organ dysfunction. The nuclear receptor peroxisome proliferator-activated receptor-gamma (PPARg) is involved in the regulation of the sepsis-induced inflammatory response. The central hypothesis is that pioglitazone reduces the inflammatory responses in children with severe sepsis and septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight range between 30 to less than or equal to 90kg
- •Have a known or suspected infection and meet criteria for severe sepsis or septic shock as defined according to the International Pediatric Sepsis Consensus Conference guidelines
排除标准
- •Are in a moribund state in which death is perceived as imminent
- •Have an advanced directive or do not resuscitate order to withhold life-sustaining
- •Have a history of cyanotic heart disease or congestive heart failure
- •Have a serum transaminase level (ALT) that exceeds about 2.5 times the upper limit of normal (>112 unit/L)
- •Are or become pregnant
- •Are already on or have a history of taking pioglitazone or rosiglitazone
- •Have type 1 or 2 diabetes
- •Have total body weight below 30 kg or above 90 kg
- •Have a serious condition, in addition to sepsis, which in the opinion of the investigator would compromise the participant
研究组 & 干预措施
Pioglitazone hydrochloride
Pioglitazone hydrochloride treatment group
干预措施: Pioglitazone hydrochloride (Drug)
结局指标
主要结局
Evaluate the Safety Profile of Pioglitazone in Patients With Severe Sepsis and Septic Shock as the Number of Hypoglycemic Events
时间窗: Assessement over five days
The number of hypoglycemic events in pioglitazone vs standard care. Hypoglycemia was defined as blood glucose level that remains \<40mg/dl despite dextrose bolus treatment.
Safety Labs - Creatinine
时间窗: Final day of study
Creatinine levels in blood from subject on the final day of enrollment
Safety Labs - Blood Urea Nitrogen (BUN)
时间窗: Final day of study
BUN levels in blood from subject on the final day of enrollment
Safety Labs - Alanine Aminotransferase (ALT)
时间窗: Final day of study
ALT levels in blood from subject on the final day of enrollment
Pioglitazone Area Under Curve Estimates by Treatment Group and Route of Administration
时间窗: five days
Pioglitazone concentration as the total area under curve divided by the number of days receiving the drug in subjects who took the drug by mouth versus by naso-gastric tube
次要结局
- Effect of Pioglitazone Area Under the Curve on Changes in IL-6(Evaluation of inflammatory biomarkers will be obtained prior to dosing for the first five days of the study)