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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51695
Enrollment
70
Registered
2023-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammation of the pancreas pancreatitis.

Interventions

After at least 48 hours of hospital admission, patients are discharged early with the use of remote home monitoring. During home monitoring, heartrate, respiratory rate, posture and movement are mon

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 38*C * heart rate > 90/min * respiratory rate >20/min * leucocytes 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.

Design outcomes

Primary

MeasureTime frame
The main endpoint of the study is the safety of early discharge with remote monitoring. Safety is defined by the incidence of unplanned hospital readmissions, the incidence of acute pancreatitis related complications and mortality, all within 30 days of hospital admission.

Secondary

MeasureTime frame
The secundary parameters of the study are length of stay in the hospital, duration of home monitoring, the amount of extra contacts between the nurse and patient, the amount of laboratory of imaging tests, adjustments in pain medication, patient satisfaction and overall costs.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)