EUCTR2012-000956-32-NL进行中（未招募）不适用
Pharmacokinetics of intravenous acetaminophen and its metabolites in morbidly obese patients - APAP study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria for morbidly obese patients:
- •- BMI > 40 kg/m2 undergoing bariatric surgery.
- •- 18 -60 years old
- •- ASA physical classification of II or III
- •- All racial and ethnic groups will be included
- •Inclusion criteria for normal weight patients:
- •- BMI between 18 and 25 kg/m2 undergoing general surgery
- •- 18 -60 years old
- •- ASA physical classification of I, II or III
- •- All racial and ethnic groups will be included
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria for all patient groups:
- •- Renal insufficiency identified by GFR < 60 ml/min/1.73m2
- •- Liver disease identified by liver function tests: ASAT, ALAT, prothrombin time, ?-GT, bilirubin, creatinine, albumin and alkaline phosphatase (ALP) ( > 3 times upper limit of normal values)
- •- Patients with Gilbert-Meulendracht syndrome
- •- Chronic alcohol intake or use of alcohol within last 72 hours
- •- Pregnancy or breastfeeding
- •- Patients who are treated with drugs know to affect CYP2E1 and UGT (UDP-glucuronyltransferases)
- •- Diabetes mellitus type II patients
- •- Acetaminophen intake before the study (24 hours before study)
研究者
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