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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05501314
Other study ID # NL81630.091.22
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2022
Est. completion date April 2025

Study information

Verified date August 2022
Source Rijnstate Hospital
Contact C.M.J. Doggen, prof. dr.
Phone +31880056042
Email REMAPstudy@rijnstate.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Acute pancreatitis is an inflammation of the pancreas which causes abdominal pain and is the most common gastro-intestinal reason for acute hospitalization in Western countries. Because care for a mild acute pancreatitis is supportive, early discharge of patients with a predicted mild course of acute pancreatitis might be safe with the use of remote home monitoring. This might reduce the demand for hospital beds and allow patients to benefit from recovering in their home environment. Therefore, the aim of this study is to assess the feasibility of a novel care pathway in which patients with a predicted mild course of acute pancreatitis are discharged early with remote home monitoring.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date April 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 (20). - 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


Intervention

Other:
Early discharge with remote home monitoring.
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 monitored every 5 minutes for at least 4 days, using a wearable sensor. Core temperature is monitored using an ear thermometer. Patients are contacted once per day by a nurse from the Virtual Monitoring Centre (VMC) to assess pancreatitis related complaints, intake of fluids and food, pain and the use of analgesics. Patients are asked to provide information to the hospital using a smartphone app.

Locations

Country Name City State
Netherlands Rijnstate Hospital Arnhem Gelderland

Sponsors (3)

Lead Sponsor Collaborator
Rijnstate Hospital Philips Research Eindhoven, University of Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient satisfaction is assessed using a satisfaction questionnaire Using a combination of two validated questionnaires After 14 days of discharge.
Other Overall costs of treatment Within 30 days of discharge
Primary Incidence (%) of unplanned hospital readmissions. To determine the feasibility of novel care pathway Within 30 days of discharge
Primary 2. Incidence (%) of pancreatitis related complications. These complications include necrotizing pancreatitis, infection, pseudocysts, new onset diabetes, recurrence of pancreatitis, cholecystitis or cholangitis. To determine the feasibility of novel care pathway Within 30 days of discharge
Primary 3. Mortality (%) of patients discharged home with remote monitoring. To determine the feasibility of novel care pathway Within 30 days of discharge
Secondary Length of stay in the hospital Within 30 days of discharge.
Secondary The amount of extra contacts between VMC-nurse or physician and the patient, in addition to the usual call once per day as documented in the smartphone app. Within 30 days of discharge
Secondary The amount of laboratory or imaging tests All bloodtests and imaging tests (US, MRI and CT-scan will be documented) Within 30 days of discharge
Secondary Amount of adjustments in analgesics needed during home monitoring Within 30 days of discharge
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