Fluid therapy based on lactated Ringer’s solution (an inexpensive, non‑patented treatment) may improve the clinical course of acute pancreatitis compared with normal saline (the most commonly used fluid therapy today), but results from small single‑center clinical trials have been contradictory.
Objectives: To compare fluid therapy based on lactated Ringer’s solution (LR group) versus normal saline (NS group) in patients with acute pancreatitis. The primary endpoint is the incidence of moderately severe or severe acute pancreatitis (according to the revised Atlanta classification). We will also evaluate relevant secondary efficacy and safety endpoints. A sex‑stratified subanalysis will be performed.
Methodology: This is a randomized, controlled, superiority, parallel‑group, open‑label, multicenter clinical trial, independent from industry funding. Adult patients with acute pancreatitis will be randomized to receive either lactated Ringer’s solution (LR) or normal saline (NS). All patients will receive fluid therapy at 1.5 ml/kg/h.
Efficacy endpoints include: local complications, systemic inflammatory response syndrome (SIRS) criteria, need for invasive treatment, need for nutritional support, ICU admission, hospital and ICU length of stay, organ failure, symptom severity assessed using the PAN‑PROMISE scale, mortality, and a composite endpoint of mortality/persistent organ failure/infected necrosis.
Safety endpoints: Criteria for fluid overload and severity of fluid overload.
Sample size: A total of 798 patients, with interim analyses planned after the inclusion of 266 and 532 patients.
