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

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dc.contributor.authorPoole, A.P.
dc.contributor.authorFinnis, M.E.
dc.contributor.authorAnstey, J.
dc.contributor.authorBellomo, R.
dc.contributor.authorBihari, S.
dc.contributor.authorBiradar, V.
dc.contributor.authorDoherty, S.
dc.contributor.authorEastwood, G.
dc.contributor.authorFinfer, S.
dc.contributor.authorFrench, C.J.
dc.contributor.authorGhosh, A.
dc.contributor.authorHeller, S.
dc.contributor.authorHorowitz, M.
dc.contributor.authorKar, P.
dc.contributor.authorKruger, P.S.
dc.contributor.authorMaiden, M.J.
dc.contributor.authorMårtensson, J.
dc.contributor.authorMcArthur, C.J.
dc.contributor.authorMcGuinness, S.P.
dc.contributor.authorSecombe, P.J.
dc.contributor.authoret al.
dc.date.issued2020
dc.description.abstractBackground: 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.
dc.description.statementofresponsibilityAlexis 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 Secombe, Antony E Tobin, Andrew A Udy, Paul J Young and Adam M Deane, on behalf of the LUCID Study Investigators and the ANZICS Clinical Trials Group
dc.identifier.citationCritical Care and Resuscitation, 2020; 22(2):133-141
dc.identifier.doi10.51893/2020.2.oa3
dc.identifier.issn1441-2772
dc.identifier.issn1441-2772
dc.identifier.orcidPoole, A.P. [0000-0002-3345-1356]
dc.identifier.orcidFinnis, M.E. [0000-0003-4125-5221]
dc.identifier.orcidHorowitz, M. [0000-0002-0942-0306]
dc.identifier.orcidMaiden, M.J. [0000-0003-4345-3213]
dc.identifier.orcidDeane, A.M. [0000-0002-7620-5577]
dc.identifier.urihttps://hdl.handle.net/2440/146093
dc.language.isoen
dc.publisherCollege of Intensive Care Medicine of Australia and New Zealand
dc.rights© 2020 College of Intensive Care Medicine of Australia and New Zealand. CC BY-NC-ND 4.0 Attribution-NonCommercial-NoDerivatives 4.0 International
dc.source.urihttps://doi.org/10.51893/2020.2.oa3
dc.subjectglucose management; intensive care unit (ICU); type 2 diabetes; blood glucose
dc.subject.meshHumans
dc.subject.meshDiabetes Mellitus, Type 2
dc.subject.meshChronic Disease
dc.subject.meshCritical Illness
dc.subject.meshBlood Glucose
dc.subject.meshCritical Care
dc.subject.meshAustralia
dc.subject.meshNew Zealand
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshClinical Trial Protocols as Topic
dc.titleStudy protocol and statistical analysis plan for the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial
dc.typeJournal article
pubs.publication-statusPublished

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