Abstract
Introduction/aim: The supraphysiologic chloride concentration of normal saline may contribute to acute kidney injury (AKI). Balanced crystalloids can decrease chloride concentration and AKI in critically ill patients. We aim to test the hypothesis that, in patients with predicted severe acute pancreatitis (pSAP), compared with saline, fluid therapy with balanced crystalloids will decrease plasma chloride concentration.Methods/Design: This is a multicenter, stepped-wedge, cluster-randomized, controlled trial. All eligible patients presenting to the 11 participating sites across China during the study period will be recruited. All sites will use saline for the first month and sequentially change to balanced crystalloids at the pre-determined and randomly allocated time point. The primary endpoint is the plasma chloride concentration on day 3 of enrollment. Secondary endpoints will include major adverse kidney events on hospital discharge or day 30 (MAKE 30) and free and alive days to day 30 for intensive care admission, invasive ventilation, vasopressors, and renal replacement therapy. Additional endpoints include daily serum chloride and sequential organ failure assessment (SOFA) score over the first seven days of enrollment.Discussion: This study will provide data to define the impact of normal saline vs. balanced crystalloids on plasma chloride concentration and clinical outcomes in pSAP patients. It will also provide the necessary data to power future large-scale randomized trials relating to fluid therapy.Ethics and Dissemination: This study was approved by the ethics committee of Jinling Hospital, Nanjing University (2020NZKY-015-01) and all the participating sites. The results of this trial will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration: The trial has been registered at the Chinese Clinical Trials Registry (ChiCTR2100044432).
Highlights
The most important determinant of mortality in patients with acute pancreatitis (AP) is organ failure [1]
There is some evidence that it increases the risk of acute kidney injury (AKI) and the need for renal replacement therapy (RRT) in critically ill patients [12, 13], but there is no reliable data in AP patients
This study aims to compare the impact of NS and a balanced crystalloid fluid on the plasma chloride concentration and the incidence of AKI in patients with predicted severe AP
Summary
The most important determinant of mortality in patients with acute pancreatitis (AP) is organ failure [1]. Renal failure or acute kidney injury (AKI) occurs in 25–59% of patients with severe AP [2, 3]. Because the chloride concentration of NS (154 mmol per liter) is significantly higher than plasma chloride concentration (94–111 mmol per liter), there is a risk of hyperchloremic metabolic acidosis. The risk of this increases with systemic inflammation and impaired renal perfusion through multiple mechanisms [11]. There is some evidence that it increases the risk of AKI and the need for renal replacement therapy (RRT) in critically ill patients [12, 13], but there is no reliable data in AP patients
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