Comparison of balanced crystalloid versus normal saline for fluid resuscitation in the early stages of acute severe pancreatitis: study protocol for a randomized controlled trial

Abstract

Abstract Background: Acute pancreatitis is a common acute inflammatory disease of the pancreas, with approximately 15-25% of them will develop into acute severe pancreatitis (SAP), and the prognosis is often extremely poor if the intervention is not actively given earlier. Previous studies confirmed that fluid resuscitation in the early stages of acute severe pancreatitis is very important. However, few studies have looked for the efficacy of balanced crystalloid in the early stages of SAP. Aim: To evaluate whether a balanced saline solution using in the initial fluid resuscitation therapy can reduce mortality and bring about fewer side effects than normal saline/0.9% saline in patients with SAP. Methods: This is a mono-center, randomized, normal saline-controlled trial which will be performed in emergency departments (ED) in China. The trial will include at least 180 patients who accord with the diagnosis of acute severe pancreatitis. Patients will be randomly assigned to either intravenous balanced crystalloid (intervention) or normal saline (control) which will be used for initial fluid resuscitation and maintenance fluids for up to 48 hours. We choose the sodium bicarbonate ringer liquid, a type of balanced salt solution which is not often studied in intervention group. The primary outcomes will be the mortality (endpoint follow-up is the 28-days survival) and the incidence of acute kidney injury (AKI). The secondary outcomes include the incidence of hyperchloremia, other electrolyte levels in the early and late stages of SAP, CRRT utility time length , ventilator utility time length, ICU length of stay and total length of hospital stay.Discussion: This trail will provide high-quality evidence for the comparative effectiveness of Bicarbonate Ringer’s solution versus normal saline for the initial fluid management of SAP patients in emergency departments.Trial registration: Chictr.org.cn, ChiCTR2200059980. Registered on 14 May 2022.