Study protocol and statistical analysis plan for the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial

Autor:	Paul Secombe, Colin McArthur, Adam M. Deane, Matthew J Maiden, Antony E Tobin, Craig French, Angaj Ghosh, Johan Mårtensson, Palash Kar, Glenn M Eastwood, Simon Finfer, Michael Horowitz, Vishwanath Biradar, Shailesh Bihari, Alexis Poole, Rinaldo Bellomo, Mark E. Finnis, Lucid Study Investigators, Andrew A. Udy, Simon Heller, James Anstey, Sarah Doherty, Peter Kruger, Paul J Young, Shay McGuinness
Rok vydání:	2020
Předmět:	medicine.medical_specialty business.industry Type 2 diabetes medicine.disease Intensive care unit law.invention Clinical trial Randomized controlled trial Reporting bias law Intensive care Diabetes mellitus Emergency medicine Clinical endpoint Medicine business
Zdroj:	Critical Care and Resuscitation. 22:133-141
ISSN:	2652-9335 1261-6001
DOI:	10.51893/2020.2.oa3
Popis:	BACKGROUND: 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. OBJECTIVE: 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. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: 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). MAIN OUTCOME MEASURES: The primary endpoint is incident hypoglycaemia (< 4.0 mmol/L) during the study intervention. Secondary endpoints include biochemical and feasibility outcomes. RESULTS AND CONCLUSION: The study protocol and statistical analysis plan described will delineate conduct and analysis of the trial, such that analytical and reporting bias are minimised. TRIAL REGISTRATION: 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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::d88344fdf8a470b2f7b1d62f68bc97c5 https://doi.org/10.51893/2020.2.oa3 Zobrazit plný text záznamu