NL-OMON51695撤回不适用
Remote home monitoring of patients with a predicted mild acute pancreatitis A safety study - REMAP
Rijnstate Ziekenhuis0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Have 2 out of 3 revised Atlanta criteria for pancreatitis:
- •- Abdominal pain consistent with acute pancreatitis
- •- serum lipase >= 3x upper limit normal (> 159 U/l)
- •- typical pancreatic abnormalities on imaging (ultrasound, CT or MRI)
- •First episode of acute pancreatitis or a prior pancreatitis more than 3
- •months ago.
- •Age >=18 years, both men and women.
- •Able and willing to provide written informed consent.
- •In possession of a working (smart)phone on which patient can be reached for
- •the duration of participation (30 days).
排除标准
- •Chronic pancreatitis according to M-ANNHEIM criteria.
- •Signs of severe pancreatitis at the moment of admission to the GE ward:
- •- serum CRP > 150 mg/l
- •- more than one SIRS criteria:
- •* temperature < 36*C or > 38*C
- •* heart rate > 90/min
- •* respiratory rate >20/min
- •* leucocytes < 4x/109l or > 12x109/l
- •MEWS (Modified Early Warning Score) >=6 or in need of ICU admission
- •Living alone or in an institution (e.g. psychiatric ward or nursing home)
- •Known sensitivity to medical adhesives
- •Known pregnancy.
- •Have one or more of the following comorbidities:
- •- Heart failure (NYHA class III or IV).
- •- COPD (Gold III-IV).
- •- Kidney disease (>G3b) and/or kidney replacement therapy.
- •- Currently undergoing oncological treatment.
- •- Use of immunosuppressants.
- •- Dysregulated or poorly controlled insulin dependent diabetes.
- •- Morbid obesity (BMI>35 kg/m2).
- •- Implantable Cardioverter Defibrillator (ICD) or Pacemaker.
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