Implementation of a remote home monitoring program for patients with a mild acute pancreatitis - A single center feasibility study (INTERACT)

Recruiting

• Conditions: Acute inflammation of the pancreas; acute pancreatitis; 10015674

• Registration Number: NL-OMON53197
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

• 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
months ago
• 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
before
• 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
day)
• Stable serum creatinine and Ringer's lactate infusion reduced to <1L/24 hours
• Independent in performing general daily life activities

Exclusion Criteria

• Chronic pancreatitis according to M-ANNHEIM criteria.
• Acute cholangitis
• Endoscopic retrograde cholangiopancreatography within the first 24 hours of
admission
• 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
emergency
• 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