1 - A Randomized Clinical Control Trial Comparing Lactated Ringers and Normal Saline in Pediatric Acute Pancreatitis

Poster Number: 1
Publication Number: 1.207

Peter R. Farrell, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States; Angelica W. DesPain, Children's Hospital of San Antonio, San Antonio, TX, United States; Peter Farmer, Nationwide Children's Hospital, Columbus, OH, United States; Leslie Farrell, University of Cincinnati College of Medicine, Cincinnati, OH, United States; Bryan Greenfield, Baylor College of Medicine, Missouri City, TX, United States; Michael E. Rogers, Cincinnati Children's Hospital, Cincinnati, OH, United States; Lindsey Hornung, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States; Esther J. Kim, Children's National Health System, Washington, DC, United States; Ryan Pearman, Alabama College of Osteopathic Medicine, Dothan, AL, United States; Beemnet Neway, New York Medical College, Valhalla, NY, United States; Tyler Thompson, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States; Sona Sehgal, Childrens National, Washington, DC, United States; Rana Ammoury, Children’s Hospital of the King’s Daughters, Norfolk, VA, United States; Maisam Abu-El-Haija, Cincinnati Children Hospital, Cincinnati, OH, United States

Background: Data driven management strategies for acute pancreatitis (AP) in pediatrics have been limited. Adult data suggests use of lactated ringers (LR) compared to normal saline (NS) resulted in favorable outcomes. The first management guideline for pediatric patients based on a standardized definition of AP severity was published in 2018; it described the need for early aggressive fluid resuscitation, but had insufficient data to recommend a specific fluid.

Objective: To evaluate the efficacy of LR as intravenous fluid during the first 48 hours of an AP episode compared with NS.

Design/Methods: Prospective multi-site randomized controlled clinical trial, started in 2016 at Children’s Hospital of The King’s Daughters, (Clinical Trials.gov NCT03242473), expanded to Children’s National Hospital, and then to Cincinnati Children’s Hospital Medical Center. Eligible patients ( < 19 years) with first episode of AP were enrolled within 6 hours of presentation and randomized to either LR or NS. A comprehensive biochemical profile was obtained at admission, and at 24 and 48 hours. Clinical decisions regarding management (e.g. discharge criteria) were determined by the primary clinical team. Primary outcomes were C-Reactive Protein (CRP) values or changes in CRP and Systemic Inflammatory Response Syndrome (SIRS); secondary outcomes were changes in labs, length of stay, and development of severe AP (SAP).

Results: There were 76 eligible patients (38 LR, 38 NS). There was no significant differences in baseline characteristics or AP etiology for either group (Table 1). There was no significant differences in initial biochemical profile except a slightly elevated anion gap in the LR group (Table 2). There was a higher proportion of patients in the LR group (32%, 12/38) discharged before 48 hours compared to NS (13%, 5/38) (Table 3). The LR group had a significantly higher rate of discharge within the first 72 hours compared to the NS group (p=0.02) (Figure 1). In the first 48 hours, there was no difference in the primary or most of the secondary outcomes measured (Table 3).Conclusion(s): Use of LR was associated with a faster rate of discharge in the first 72 hours. This reduction in length of hospitalization has significant implications for patients as well as healthcare costs. This data also suggests that early resuscitation with LR may be beneficial to recovery, particularly in patients more likely to have mild AP. No other significant differences in overall outcomes were identified with the use of LR or NS during hospitalization for AP in this study. Future pediatric AP studies will be required to confirm these findings.
Table1 and Table 2Table 1: Baseline Patient Demographics and Etiologies. Table 2: Biochemical/Inflammatory Profile on Admission.
Table 3 and Figure 1Table 3: Outcome measures between the two treatment arms. Figure 1: Discharge rate over the first 72 hours.