Effects of Different Omeprazole Dosing on Gastric pH in Non- Variceal Upper Gastrointestinal Bleeding: A Randomized Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Percentage of time at pH >4.0 and pH >6.0
研究概览
简要总结
The aim of the study is to identify the best method of omeprazole (OME) application with respect to intragastric pH, cytochrome P450 2C19 (CYP2C19) genotype and phenotype.
详细描述
The patients with non-variceal upper gastrointestinal bleeding (NVUGIB) are prospectively enrolled. After the achievement of endoscopic hemostasis, the patients are randomized to 40-mg intravenous (i.v.) OME bolus injection every 12 h or 8-mg/h continuous i.v. infusion for 72 h after an 80-mg i.v. OME bolus administration. The intragastric pH is recorded for 72 h. The CYP2C19 variant alleles (*2, *3, *17) are analyzed and the serum concentrations of OME and 5-hydroxyomeprazole (5-OH OME) are determined. The diagnosis of Helicobacter pylori infection was based on the results of the rapid urease test performed on stomach mucosa biopsies (antrum and angle) and on the results of the stool antigen test.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent must be obtained before any treatment or assessment is performed
- •patients admitted with upper gastrointestinal bleeding (UGIB) symptoms to the Emergency Department of the University Hospital of Bialystok (Bialystok, Poland)
排除标准
- •pregnancy
- •age >90 years
- •lack of written consent
- •recent treatment with certain medications, including PPIs, H2-receptor antagonists (H2RA), antacids, steroids, oral contraceptives, clopidogrel, prasugrel and clarithromycin
- •the presence of variceal UGIB
- •history of surgery of upper gastro-intestinal tract
研究组 & 干预措施
omeprazole infusion (OI) group
After successful endoscopic hemostasis, the patients are given an 80-mg i.v. omeprazole bolus. The OI group is then treated with an 8-mg/h continuous i.v. infusion of OME for 72 h.
干预措施: Omeprazole (Drug)
omeprazole bolus (OB) group
After successful endoscopic hemostasis, the patients are given an 80-mg i.v. omeprazole bolus. The OB group receives a 40-mg i.v. bolus of OME every 12 h.
干预措施: Omeprazole (Drug)
结局指标
主要结局
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Percentage of time at pH >4.0 and pH >6.0
时间窗: 72 hours
intragastric pH profiles
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: pH at specified time after the initial OME 80 mg i.v. bolus
时间窗: 72 hours
intragastric pH profiles
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Helicobacter pylori infection
时间窗: 72 hours
intragastric pH profiles
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: CYP2C19 variant alleles (*2, *3, *17)
时间窗: 72 hours
intragastric pH profiles
次要结局
未报告次要终点