Remote Home Monitoring in Mild Acute Pancreatitis

Launched by RIJNSTATE HOSPITAL · Dec 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to care for patients with mild acute pancreatitis, which is an inflammation of the pancreas causing severe abdominal pain. The goal is to see if patients can safely recover at home using remote monitoring instead of staying in the hospital. By using this method, the trial hopes to free up hospital beds and allow patients to be more comfortable in their own environment. To participate, patients must be at least 18 years old, have mild acute pancreatitis, and meet certain health criteria, such as having a stable condition and being able to manage daily activities independently.

Participants in the trial will be discharged from the hospital after at least 48 hours, and for the next four days, they will receive support from a nurse through daily phone calls. They will also use a smartphone app to report their symptoms and receive guidance on managing their condition. The trial aims to assess how well this home monitoring program works and how satisfied patients are with the care they receive. It’s important to note that patients with more severe health issues or certain conditions will not be eligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Acute pancreatitis according to the revised Atlanta criteria for pancreatitis(23). 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/109/L 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(24).
• • 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