Buffered salt solution versus 0.9% sodium chloride as fluid therapy for patients presenting with moderate to severe diabetic ketoacidosis: Study protocol for a Phase-3 cluster-crossover, blinded, randomised, controlled trial.

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Buffered salt solution versus 0.9% sodium chloride as fluid therapy for patients presenting with moderate to severe diabetic ketoacidosis: Study protocol for a Phase-3 cluster-crossover, blinded, randomised, controlled trial.

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Objective: To examine the risk and protective factors for severe and recurrent diabetic ketoacidosis (DKA) in a large sample of children in the Southwestern United States. Methods: Retrospective chart review of children age 0-18 years with type 1 diabetes (T1D) seen at a large children's hospital/integrated care delivery system between October 2019 and December 2022. Data from the preceding 2 years were used to predict postdiagnosis DKA in each subsequent year. Logistic regression and recursive feature elimination (RFE) were used to select significant predictors of any DKA, severe DKA, and recurrent DKA. Model performance was evaluated using fivefold cross-validation, with area under the curve in the receiver operating characteristic plot as the performance metric. Results: Records were obtained for 4649 encounters, representing 1850 patients and 846 prior DKA events. Based on RFE, single prior DKA, recurrent prior DKA, and hemoglobin A1c were significant shared predictors for subsequent DKA, severe DKA, and recurrent DKA, and female sex was positively associated with any DKA and recurrent DKA. The model for recurrent DKA also included age between 10 and 14 years as an unshared risk factor, and Hispanic ethnicity and use of an insulin pump (with or without automated insulin delivery) as unshared protective factors. Incidence of severe DKA was highly correlated (r = 0.95) with number of prior DKA events. Black and female patients were more likely to experience multiple recurrent DKA episodes and repeated episodes of severe DKA. Conclusions: Severe and recurrent DKA have both shared and unshared risk factors. Severe DKA may be a singular phenomenon in most cases, although a subset of patients (primarily Black and female) experience repeated severe events, placing them at high risk for adverse health outcomes. Recurrent DKA appears to be more of a chronic issue, although a number of variables emerged as protective factors, suggesting ways in which recurrent DKA might be prevented.

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