NL-OMON53197招募中不适用
Implementation of a remote home monitoring program for patients with a mild acute pancreatitis - A single center feasibility study (INTERACT) - INTERACT
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
- 招募中
- 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
- •Acute pancreatitis according to the revised Atlanta criteria for pancreatiti.
- •Which is at least 2 of the following 3 criteria:
- •- 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
- •Age >=18 years, both men and women
- •Able and willing to provide written informed consent in Dutch
- •In possession of a working (smart)phone on which patient can be reached for
- •the duration of participation (30 days)
- •<=1 SIRS criteria:
- •* temperature < 36*C or > 38*C
- •* heart rate > 90/min
- •* respiratory rate >20/min
- •* leucocytes < 4x/109l or > 12x109/l
- •Serum CRP <= 150 mg/l on day of discharge and with a decreasing trend in days
- •Pain score (NRS) <=6 with or without the use of pain medication
- •Adequate intake of oral food and fluids (= >=2 small meals and >=1L fluids per
- •Stable serum creatinine and Ringer's lactate infusion reduced to <1L/24 hours
- •Independent in performing general daily life activities
排除标准
- •Chronic pancreatitis according to M-ANNHEIM criteria.
- •Acute cholangitis
- •Endoscopic retrograde cholangiopancreatography within the first 24 hours of
- •MEWS (Modified Early Warning Score) >=6 or in need of ICU admission
- •Living in an institution (e.g. psychiatric ward or nursing home), or the
- •absence of a household member capable of alerting the hospital in case of an
- •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
研究者
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