BASal-bolus Insulin therapy in Critically ill patients (BASIC): A randomized controlled trial protocol
Basal bolus insulin in critically ill patients
DOI:
https://doi.org/10.54205/ccc.v32.268831Keywords:
Basal bolus insulin, Sliding scale insulin, Critically ill patientAbstract
Background: Controlling blood glucose levels is crucial for optimizing outcomes in critically ill patients. While the sliding-scale insulin regimen is common, the efficacy of basal-bolus insulin therapy, using insulin glargine and insulin aspart, is less explored in critical care settings.
Objective: This study investigates the efficacy and safety of basal-bolus insulin therapy compared to sliding-scale insulin in managing hyperglycemia in critically ill patients in a medical intensive care unit (ICU).
Methods: The BASal-Bolus Insulin Therapy in Critically Ill Patients (BASIC) trial is a single-center, open-label randomized controlled trial at Srinagarind Hospital, Thailand. The study will enroll adult critically ill patients admitted to the medical ICU with capillary blood glucose (CBG) levels between 180 and 400 mg/dL. Participants will be randomized (1:1) to receive either basal-bolus insulin therapy or sliding-scale insulin (control). The primary endpoint is the percentage of CBG within the target range of 140–180 mg/dL. The secondary outcomes include daily mean CBG levels, glucose variability index, 28-day mortality, length of stay in the ICU, incidence of nosocomial infections, ventilator-free days within 28 days, and occurrences of hypoglycemia.
Hypothesis: Basal-bolus insulin regimen has a higher efficacy in glycemic control compared to a sliding-scale regimen in critically ill medical patients.
Discussion: Evidence regarding the effectiveness of the basal-bolus insulin regimen in critically ill patients is limited, with most existing studies focusing on non-critically ill populations. This study addresses this gap by comparing the basal-bolus approach to the conventional sliding-scale insulin regimen. This trial aims to provide valuable insights into optimizing glycemic control in critically ill patients, potentially leading to improved clinical outcomes.
Ethics and dissemination: This study obtained approval from the Center for Ethics in Human Research at Khon Kaen University (Ethics Committee number: HE661013)
Trial registration: TCTR20230410009
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