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

Alexis P. Poole, Mark E. Finnis, James Anstey, Rinaldo Bellomo, Shailesh Bihari, Vishwanath Biradar, Sarah Doherty, Glenn Eastwood, Simon Finfer, Craig J. French, Angaj Ghosh, Simon Heller, Michael Horowitz, Palash Kar, Peter S. Kruger, Matthew J. Maiden, Johan Mårtensson, Colin J. McArthur, Shay P. McGuinness, Paul J. SecombeAntony E. Tobin, Andrew A. Udy, Paul J. Young, Adam M. Deane, LUCID Study Investigators, ANZICS Clinical Trials Group

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)133-141
Number of pages9
JournalCritical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine
Volume22
Issue number2
Publication statusPublished - 1 Jun 2020

Keywords

  • Type 2 Diabetes
  • (NICE-SUGAR) trial
  • blood glucose concentrations
  • (LUCID) trial

Fingerprint Dive into the research topics of 'Study protocol and statistical analysis plan for the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial'. Together they form a unique fingerprint.

  • Cite this

    Poole, A. P., Finnis, M. E., Anstey, J., Bellomo, R., Bihari, S., Biradar, V., Doherty, S., Eastwood, G., Finfer, S., French, C. J., Ghosh, A., Heller, S., Horowitz, M., Kar, P., Kruger, P. S., Maiden, M. J., Mårtensson, J., McArthur, C. J., McGuinness, S. P., ... ANZICS Clinical Trials Group (2020). Study protocol and statistical analysis plan for the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial. Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine, 22(2), 133-141. https://ccr.cicm.org.au/journal-editions/2020/june/22/original-aricles/article-10