Preliminary Results of Adding Meglumine Sodium Succinate to the Treatment of Patients with Moderate to Severe Acute Pancreatitis

Abstract

Objective: to develop criteria of inclusion/noninclusion of patients for further randomized clinical trial of meglumine sodium succinate in patients with acute pancreatitis based on analysis of individual outcomes.Material and methods. The efficacy of treatment of patients with moderate-to-severe and severe acute pancreatitis (n=100, 23–65 years old) with meglumine sodium succinate (intravenous drip infusions, 10 ml/kg daily, for 11 days) was assessed. Data were collected by 10 medical centers as a part of an observational program developed in accordance with the requirements of the Guidelines and Clinical Trial Committee of the AllRussia Public Organization «Federation of Anesthesiologists and Reanimatologists» (FAR) and approved by local ethical committees of the institutions. Treatment was prescribed in accordance with national and international standards. The patients were divided into two groups based on the outcome: group 1 (n=81) included patients who survived, while the patients of group 2 (n=19) died. We analyzed demographic characteristics of the groups, life and illness history, physical examination, routine laboratory and instrumental investigation data. The obtained results were statistically analyzed.Results. We identified several factors occurring during hospitalization and/or transfer to intensive care unit (ICU), which could be predictors of adverse outcome and had varying impact on the risk of death in patients treated with the study drug. High-risk factors included stupor, platelet count below 248.5×109/l, base excess (BE) less than -2.9 mmol/l, and urea above 11.85 mmol/l. Risk factors included body temperature below 37.1°C, plasma creatinine above 237 µmol/l, and glucose above 9.45 mmol/l. Mottled skin and plasma ionized calcium levels below 1.13 mmol/l were considered probable risk factors.Conclusion. Determined prognostically significant predictors of adverse outcome in patients with acute pancreatitis receiving Reamberin should be considered when selecting inclusion/exclusion criteria for the randomized controlled comparative clinical study of the efficacy of meglumine sodium succinate in patients with acute pancreatitis.

Keywords

• evidence-based medicine
• randomized clinical trials
• acute pancreatitis
• intensive care
• reamberine
• meglumine sodium succinate