An interventional study of Control and Experimental in Acute Pancreatitis, sponsored by Hospital Universitari de Bellvitge. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Hospital Universitari de Bellvitge · Not applicable, Interventional, and Supportive care
Acute pancreatitis accounts for a large number of hospital admissions every year. Some studies have shown that early oral feeding protocols are safe, and one previous study suggests the possibility of home care for mild acute pancreatitis.
Approximately 80% of all cases of acute pancreatitis are mild and only require supportive care for pain and nausea control and an adequate fluid replacement. Currently, all patients in our setting diagnosed with mild acute pancreatitis are admitted to a conventional hospitalization ward under the supervision of the Digestive and General Surgery Department or the Gastroenterology Department. Symptomatic treatment is administered, and abdominal ultrasound is performed to assess the cause of pancreatic inflammation. The remaining 20% fulfill the severity criteria from its onset onwards and require intensive care support.
We will conduct a multicenter randomized controlled clinical trial to compare two different approaches to mild non-alcoholic acute pancreatitis: hospital admission and outpatient management.
752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's planned enrollment of 308 is above the median of 80 across 448 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Hospital Universitari de Bellvitge is the lead sponsor of 118 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with mild acute pancreatitis based on at least two of the three following criteria:
Age ≥18 years and \<80 years
Absence of potential pancreatitis-related severity criteria:
Patients with good pain response to 12-hour supportive care in the ER (VAS \<4) or adequate oral feeding tolerability.
Absence of local or systemic complications of acute pancreatitis on imaging tests.
Adequate cognitive capacity and without any previous diagnose of psychiatric disease.
Patients who meet each participating hospital home care criteria. Patients who give their written informed consent to participate.
EXCLUSION CRITERIA
Past medical history of pancreatic disease:
Comorbidities that required previous hospitalization (myocardial infarction, liver cirrhosis, chronic kidney disease, or chronic lung disease).
BMI ≥35 Kg/m2 Patients who refuse to participate in the study.
Patients with mild acute pancreatitis randomized to in-hospital care.
Other: Control
Patients with mild acute pancreatitis randomized to early discharge and outpatient clinic follow-up.
Other: Experimental
In-patient care.
Also known as: HOSPIT
Early discharge and outpatient follow-up.
Also known as: HOME
7-day (after randomization) treatment failure rate
Treatment failure is defined as a VAS \>3 and/or oral feeding intolerance (nausea, repeated vomiting episodes, early satiety).
Time frame: 7 days
Cumulative incidence of complications secondary to acute pancreatitis during the first 30 days after diagnosis
Complications include, but are not limited to, abscess formation, pseudocysts, local necrosis, kidney failure, respiratory failure.
Time frame: 30 days
Hospital readmission during the first 30 days after diagnosis
Number of patients readmitted to the hospital during the first 30 days after diagnosis.
Time frame: 30 days
Cumulative incidence of mortality during the first 30 days after diagnosis
30-day mortality
Time frame: 30 days
Estimated costs of each intervention
Time frame: 7 days
Median (95%CI) Charlson Comorbidity Score per group
Time frame: 7 days
Median (95%CI) EuroQoL 5 Dimensions Quality of Life Score
Time frame: 7 days
Plan to share: Undecided
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Hospital Universitari de Bellvitge