Status:
UNKNOWN
Remote Home Monitoring in Mild Acute Pancreatitis
Lead Sponsor:
Rijnstate Hospital
Collaborating Sponsors:
University of Twente
Philips Research Eindhoven
Conditions:
Pancreatitis, Acute
Remote Home Monitoring
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 2 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06178172
Start Date
January 2 2024
End Date
October 2 2025
Last Update
December 20 2023
Active Locations (2)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6815 AD
2
Rijnstate Hospital
Arnhem, Netherlands