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|Title:||Study protocol and statistical analysis plan for the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial.|
|Authors:||Poole, Alexis P;Finnis, Mark E;Anstey, James;Bellomo, Rinaldo;Bihari, Shailesh;Biradar, Vishwanath;Doherty, Sarah;Eastwood, Glenn;Finfer, Simon;French, Craig J;Ghosh, Angaj;Heller, Simon;Horowitz, Michael;Kar, Palash;Kruger, Peter S;Maiden, Matthew J;Mårtensson, Johan;McArthur, Colin J;McGuinness, Shay P;Secombe, Paul J;Tobin, Antony E;Udy, Andrew A;Young, Paul J;Deane, Adam M|
|Affiliation:||The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia|
Department of Critical Care Medicine, Auckland District Health Board, Auckland, New Zealand
Cardiothoracic and Vascular Intensive Care and High Dependency Unit, Auckland District Health Board, Auckland, New Zealand
Medical Research Institute of New Zealand, Wellington, New Zealand
Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide, SA, Australia
Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia
Department of Intensive Care, Princess Alexandra Hospital, Brisbane, QLD, Australia
Department of Intensive Care, Alice Springs Hospital, Alice Springs, NT, Australia
Department of Intensive Care, St Vincent's Hospital Melbourne, Melbourne, VIC, Australia
Department of Intensive Care, The Alfred Hospital, Melbourne, VIC, Australia
Department of Intensive Care, Royal Melbourne Hospital, Melbourne, VIC, Australia
Department of Intensive Care, Austin Health, Heidelberg, Victoria, Australia
Department of Intensive and Critical Care Unit, Flinders Medical Centre, Adelaide, SA, Australia
Department of Intensive Care, Lyell McEwin Hospital, Adelaide, SA, Australia
Department of Intensive Care, Western Health, Melbourne, VIC, Australia
Intensive Care Unit, Northern Health, Melbourne, VIC, Australia
Clinical Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, United Kingdom..
Section of Anaesthesia and Intensive Care Medicine, Department of Physiology and Pharmacology, Karolinska Institutet, Solna, Sweden..
|Citation:||Critical Care and Resuscitation 2020; 22(2): 133-141|
|Abstract:||Contemporary glucose management of intensive care unit (ICU) patients with type 2 diabetes is based on trial data derived predominantly from patients without type 2 diabetes. This is despite the recognition that patients with type 2 diabetes may be relatively more tolerant of hyperglycaemia and more susceptible to hypoglycaemia. It is uncertain whether glucose targets should be more liberal in patients with type 2 diabetes. To detail the protocol, analysis and reporting plans for a randomised clinical trial - the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial - which will evaluate the risks and benefits of targeting a higher blood glucose range in patients with type 2 diabetes. A multicentre, parallel group, open label phase 2B randomised controlled clinical trial of 450 critically ill patients with type 2 diabetes. Patients will be randomised 1:1 to liberal blood glucose (target 10.0-14.0 mmol/L) or usual care (target 6.0-10.0 mmol/L). The primary endpoint is incident hypoglycaemia (< 4.0 mmol/L) during the study intervention. Secondary endpoints include biochemical and feasibility outcomes. The study protocol and statistical analysis plan described will delineate conduct and analysis of the trial, such that analytical and reporting bias are minimised. This trial has been registered on the Australian New Zealand Clinical Trials Registry (ACTRN No. 12616001135404) and has been endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group.|
|Appears in Collections:||Journal articles|
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