Acute pancreatitis Digestive System Acute pancreatitis
Conditions
Interventions
Patients admitted with acute pancreatitis will be randomised using sealed envelope (www.sealedenvelope.com) to one of the following groups for the first 48 hours of the hospital stay:
Standard care:
Sponsors
Royal Free London NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acute pancreatitis will be confirmed by international consensus criteria for diagnosis of acute pancreatitis i.e. two of the following three features: 1. Abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe, epigastric pain often radiating to the back) 2. Serum amylase or lipase activity at least three times greater than the upper limit of normal 3. Characteristic findings of acute pancreatitis on contrast-enhanced computed tomography (CECT) and less commonly magnetic resonance imaging (MRI) or transabdominal ultrasonography
Exclusion criteria
Exclusion criteria: 1. Patients transferred for the management of complications of acute pancreatitis 2. Patients requiring immediate admission to the Intensive Therapy Unit (ITU) 3. Chronic pancreatitis in whom an acute exacerbation cannot be confirmed 4. Current or past cardiac failure 5. Unable to provide fully informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility assessed at the end of the study period by the following criteria: 1. A consent rate of at least 30% is achieved 2. The ability to recruit 50 patients to the study at the two sites over 17 months 3. GDFT can be successfully performed within 6 hours of diagnosis of acute pancreatitis and can be continued until at least 48 hours after admission in a minimum of 80% of participants randomised to GDFT 4. The complication rate in the intervention group is not more than 10% higher than that of the control group at 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| A number of outcome measures will also be collected in order to assess safety and determine the optimum primary outcome and for a subsequent larger randomised controlled trial in which both clinical and cost effectiveness shall be assessed: 1. Mortality, recorded up to the end of the 3 month follow-up period 2. Health-related quality of life (HRQoL), assessed by EQ-5D-5L questionnaire at admission (estimated from information prior to onset of acute pancreatitis), 7 days, 30 days and 90 days following the attack of pancreatitis 3. Outcomes including treatment-related adverse events and serious adverse events as well as proportion of people with severe acute pancreatitis, necrotising pancreatitis, infected pancreatic necrosis, requiring intensive therapy unit (ITU) stay, requiring renal replacement therapy, requiring ventilation, surgical interventions for complications related to pancreatitis, positive blood cultures, duration of ventilation, length of ITU and hospital stay, time to return to pre-pancreatitis activities, number of work days lost (in those who work), and costs (NHS and PSS (personal social services) perspective, collected until discharge and at 30 and 90 days follow-up 4. Routine blood tests including inflammatory markers (C-reactive protein, WCC), liver function tests, clotting, renal function and arterial blood gases, recorded daily for up to 7 days after acute onset of pancreatitis and twice weekly until discharge (if longer admission than 7 days) 5. Serum samples collected by venesection for markers of endothelial injury, collected at the start of intervention (t=0), 6, 12, 24 and 48 hours 6. Microcirculatory changes assessed using sublingual videomicroscopy (Cytocam-IDF) at baseline and post-intervention (48 hours) | — |
Countries
England, United Kingdom
Contacts
Public ContactFarid Froghi
Outcome results
None listed