Balanced Electrolyte solution versus Saline Trial for Diabetic KetoAcidosis- Statistical Analysis Plan

IntroductionFluid therapy is a cornerstone of acute management of diabetic ketoacidosis (DKA), yet the optimal fluid type is unknown. The Balanced Electrolyte Solution versus Saline Trial for Diabetic Ketoacidosis (BEST-DKA) trial has been designed to test the hypothesis that for patients with moderate to severe DKA, fluid therapy with Plasma-Lyte 148, compared with 0.9% saline, will lead to increased days alive and out of hospital to day-28 after enrolment. PurposeTo describe the statistical analysis plan for the BEST-DKA trial. Design, settings and participants: BEST-DKA is a currently recruiting cluster-randomised, crossover randomised controlled trial which will recruit a minimum of 400 patients with moderate or severe DKA at 22 hospitals in Australia, which will provide >91.4% power to detect a change of 2 days in the primary outcome, days alive and out of hospital to day-28 after enrolment. Hospitals will be randomised to either blinded saline or Plasma-Lyte 148 for a 12-month period, and then crossover to the alternate fluid for the next 12-month period. ConclusionBEST-DKA started enrolment in March 2024 and recruitment is on target with scheduled completion in July 2026. 1 Administrative information1.1 Study identifiersO_LIClinicalTrials.gov register Identifier: NCT05752279. C_LI 1.2 Revision history O_TBL View this table: org.highwire.dtl.DTLVardef@1260f2forg.highwire.dtl.DTLVardef@1aee8b0org.highwire.dtl.DTLVardef@2e86f5org.highwire.dtl.DTLVardef@9e6e1aorg.highwire.dtl.DTLVardef@14ea7bf_HPS_FORMAT_FIGEXP M_TBL C_TBL 1.3 Contributors to the statistical analysis plan1.3.1 Roles and responsibilities O_TBL View this table: org.highwire.dtl.DTLVardef@e72de5org.highwire.dtl.DTLVardef@17617e6org.highwire.dtl.DTLVardef@1b3114org.highwire.dtl.DTLVardef@1332eaborg.highwire.dtl.DTLVardef@13cf3bb_HPS_FORMAT_FIGEXP M_TBL C_TBL 1.3.2 ApprovalsThe undersigned have reviewed this plan and approve it as final. They find it to be consistent with the requirements of the protocol as it applies to their respective areas. They also find it to be compliant with ICH-E9 principles and in particular confirm that this analysis plan was developed in a completely blinded manner, i.e. without knowledge of the effect of the intervention(s) being assessed. O_TBL View this table: org.highwire.dtl.DTLVardef@a5b932org.highwire.dtl.DTLVardef@21b229org.highwire.dtl.DTLVardef@37cbdforg.highwire.dtl.DTLVardef@129af05org.highwire.dtl.DTLVardef@1a1b175_HPS_FORMAT_FIGEXP M_TBL C_TBL