Outcome of Critically ill Patients Undergoing Mandatory Insulin Therapy Compared to Usual Care Insulin Therapy: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Observational and interventional studies in patients with both acute medical conditions and long-standing diabetes have shown that improved blood glucose control confers a survival advantage or reduces complication rates. Policies of "tight" glycaemic control were rapidly adopted by many general intensive care units (ICUs) worldwide in the mid 00's, even though the results of the studies were not generalizable to mixed medical/surgical ICUs with different intravenous feeding policies.

OBJECTIVE: The primary objective of the study is to assess the safety of mandatory insulin infusion in critically ill patients in a general ICU setting.

METHODS: This protocol summarizes the rationale and design of a randomized, controlled, single-center trial investigating the effect of mandatory insulin therapy versus usual care insulin therapy for those patients admitted for a stay of longer than 48 hours. In total, 109 critically ill adults predicted to stay in intensive care for longer than 48 hours consented. The primary outcome is to determine the safety of mandatory insulin therapy in critically ill patients using the number of episodes of hypoglycaemia and hypokalaemia per unit length of stay in intensive care. Secondary outcomes include the duration of mechanical ventilation, duration of ICU and hospital stay, hospital mortality, and measures of renal, hepatic, and haematological dysfunction.

RESULTS: The project was funded in 2005 and enrolment was completed 2007. Data analysis is currently underway and the first results are expected to be submitted for publication in 2018.

CONCLUSIONS: This protocol for a randomized controlled trial investigating the effect of mandatory insulin therapy should provide an answer to a key question for the management of patients in the ICU and ultimately improving outcome.

TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number ISRCTN00550641; https://www.isrctn.com/ISRCTN00550641 (Archived at WebCite: https://www.webcitation.org/6xk8NXxNv).