Oral Versus Intravenous Omeprazole in Management of Bleeding Peptic Ulcer: Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 主要终点
- recurrent bleeding
研究概览
简要总结
Find out if there is a significant difference between clinical outcome among the patients with bleeding peptic ulcer treated with oral omeprazole compared to those treated with intravenous omeprazole.
详细描述
Globally, Peptic ulcer disease is the most common cause of upper gastrointestinal bleeding (UGIB), accounting for about 50% of cases. It remains a serious medical problem with significant morbidity and mortality (1, 2). However, in Egypt, bleeding peptic ulcer comes second to the bleeding varices in order of frequency (approximately 30%) (3).
Over the past 20 years, mortality resulting from bleeding peptic ulcer significantly decreased through researches on primary endoscopic hemostasis, due to improvement in pre- and post-endoscopic management, as well as identification of patients at a risk of catastrophic events-for close observation and focused intensive management (4).However, the risk of patients with bleeding peptic ulcers significantly increased owing to the aging population with multiple comorbidities, as well as the increasing use of aspirin and non-steroidal anti-inflammatory drugs (5).
Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcer and is now recommended as the first hemostatic modality for these patients. However, there is a high risk of peptic ulcer re-bleeding in 14-36% of patients, in spite of efficient endoscopic intervention (6).
Intravenous proton pump inhibitors (PPIs) are effective as adjuvant pharmacotherapy in preventing re-bleeding in these patients (7).
Gastric acid inhibits clot formation and promotes clot lyses and accordingly, disturbs hemostasis of ulcers in the stomach and duodenum (8). Therefore, reduction of gastric acid secretion can prevent ulcer re-bleeding.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Peptic ulcer of the esophagus (lower part), stomach, and duodenum with one or more endoscopic signs of high risk for re-bleeding (ulcer bed exhibiting active bleeding (spurting/oozing), non-bleeding visible vessel, and adherent clot).
排除标准
- •Pregnant patients.
- •Pediatric patients (less than 18 years).
- •Ulcer with endoscopic signs suspicious of neoplastic disease (greater than 3 cm, irregular shape, uneven base, irregular edges, moth eaten appearance of peri ulcer folds, associated with a mass)
- •Use of PPI 14 days or less before enrollment.
- •Other sources of UGIB.
- •Bleeding tendency (platelet count <50,000/mL, prothrombin time > 14 sec, prothrombin concentration <30%, anticoagulant therapy)
研究组 & 干预措施
oral omeprazole
oral omeprazole in bleeding peptic ulcer after endoscopic therapy 40 mg twice daily for 72 hours
干预措施: Omeprazole (Drug)
intravenous omeprazole
intravenous omeprazole in bleeding peptic ulcer after endoscopic therapy as continuous infusion at rate of 8 mg/hour for 72 hours
干预措施: Omeprazole (Drug)
结局指标
主要结局
recurrent bleeding
时间窗: 15 days
Re-bleeding will be suspected if hematemesis or melena recur or of the patient develop one or more of the following: orthostatic hypotension, unstable vital signs (systolic blood pressure\< 90 mmHg and pulse rate\> 120/min), reduction of hemoglobin level\> 2 gm/dL (despite blood transfusion), during 24 hour period.
次要结局
- -Length of hospital stay. -Admission to ICU. - Blood transfusion (number of units of packes RBCs) -Angioembolization. -Surgery for uncontrolled recurrent bleeding.(15 days)
研究者
Zeinab Nasr El Din Ahmed
Principle Investigator
Assiut University