Remote home monitoring of patients with a predicted mild acute pancreatitis A safety study

Withdrawn

Conditions: inflammation of the pancreas
pancreatitis.
10015674

Registration Number: NL-OMON51695

Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of the study is the safety of early discharge with remote<br /><br>monitoring. Safety is defined by the incidence of unplanned hospital<br /><br>readmissions, the incidence of acute pancreatitis related complications and<br /><br>mortality, all within 30 days of hospital admission. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary parameters of the study are length of stay in the hospital,<br /><br>duration of home monitoring, the amount of extra contacts between the nurse and<br /><br>patient, the amount of laboratory of imaging tests, adjustments in pain<br /><br>medication, patient satisfaction and overall costs.</p><br>