PlasmaLyte, Lactated Ringer's, or Normal Saline resuscitation in acute pancreatitis: a single-center, pragmatic, cluster-randomized trial.

Abstract

Background/aims: The optimal resuscitation fluid for acute pancreatitis (AP) remains uncertain. This study evaluated the effects of PlasmaLyte (PL), Lactated Ringer's solution (LR), and Normal Saline (NS) in patients with early AP.

Methods: A single-center, pragmatic, unblinded, monthly cluster-randomized trial compared PL, LR, and NS in patients with AP who presented within 6 h of symptom onset and had no evidence of overt severe disease at enrollment. The primary outcome was the change in systemic inflammatory response syndrome (SIRS) prevalence at 24 h. Secondary outcomes included clinical outcomes and biochemical changes after fluid resuscitation.

Results: Sixty-six patients were enrolled (PL 21, LR 24, NS 21). Baseline SIRS prevalence was 23.8% in the PL group, 29.2% in the LR group, and 19.0% in the NS group; at 24 h, SIRS prevalence decreased to 4.8%, 12.5%, and 9.5%, respectively. This corresponded to relative reductions of 80.0% in PL, 57.1% in LR, and 50.0% in NS, without a statistically significant between-group difference (P = 0.668). No significant differences were observed in major clinical outcomes. At 24 h, potassium was higher in PL than in LR, chloride was higher in NS than in PL, and pH, bicarbonate, and base excess were lower in NS than in balanced crystalloid groups. These biochemical differences should be interpreted cautiously because of the small sample size and cluster design.

Conclusions: In this small pragmatic trial, PL, LR, and NS showed no significant difference in the primary clinical endpoint. However, balanced crystalloids were associated with more favorable acid-base profiles than NS. These findings are exploratory and hypothesis-generating and require confirmation in larger multicenter trials with appropriate cluster-adjusted or individually randomized designs.

Trial registration: Clinical Research Information Service (CRIS), KCT0007422. Registered June 20, 2022, https://cris.nih.go.kr .