Evaluation of the Incidence and Relevance of the Adrenal Insufficiency in Critical Emergencies in Digestive Diseases (GI Bleeding and Acute Pancreatitis)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Relative adrenal insufficiency
研究概览
简要总结
Observational study about the incidence of relative adrenal insufficiency in patients with cirrhosis and acute variceal bleeding; in patients with acute peptic gastrointestinal bleeding and without liver disease; and in patients with severe acute pancreatitis.
This is a study using pharmaceutical specialties in the approved conditions of use.
详细描述
Observational, prospective, open-label, in-patient study, that includes patients with upper gastrointestinal bleeding of variceal or peptic origin, and in patients with severe acute pancreatitis.
The adrenal function of every patient included will be evaluated in the first 24 hours of admission This assessment shall be performed using the corticotropin-stimulation short test (synacthen test), that includes serum and saliva determination of cortisol, in basal conditions and 30 and 60 minutes after the administration of 250 ug of corticotropin synthetic (Synacthen, Novartis Pharma AG, Basel, Switzerland).
The cortisol levels will be determined by competitive immunoassay using direct chemoluminescence technology (Bayer Corporation, Pittsburgh, PA, USA).
In patients with severe acute pancreatitis all of these determinations will be repeated at the third day of admission.
Several other clinical and biochemical features will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Age <18 years and >80 years.
- •Pregnancy.
- •Patient refusal to participate in the study.
- •Prior corticosteroids treatment(oral or topical).
- •Treatment during the 30 days prior to inclusion with any of the following drugs: contraception, etomidate, ketoconazole, rifampin or phenytoin.
- •History of cranial trauma or surgery.
- •Any malignancy in treatment or progression.
- •HIV infection.
- •Prior known adrenal pathology.
- •Patients not eligible to any active treatment because the existence of any clinical condition considered terminal.
- •Patients with associated traumatic blood loss, or any other extraintestinal source of active bleeding.
- •Patients who have been previously included in this study.
结局指标
主要结局
Relative adrenal insufficiency
时间窗: 1 week
次要结局
- Need for vasopressive drugs(45 days)
- Therapeutic failure(45 days)
- Survival(45 days)
- Variations in portal hypertension.(7 days)