دورية أكاديمية
Study protocol and statistical analysis plan for the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial.
| العنوان: | 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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| المؤلفون: | 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 |
| المصدر: | 22. |
| بيانات النشر: | Australia |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Australia, Blood Glucose/*metabolism, Chronic Disease, Clinical Trial Protocols as Topic, Critical Care, Critical Illness, Diabetes Mellitus, Type 2/blood/*complications, Humans, New Zealand, Randomized Controlled Trials as Topic |
| الوصف: | 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. ; Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia. Alexis.Poole@adelaide.edu.au. ; Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia. ; Department of Intensive Care, Royal Melbourne Hospital, Melbourne, VIC, Australia. ; Department of Intensive Care, Austin Hospital, Melbourne, VIC, Australia. ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | 133-141 |
| اللغة: | English |
| العلاقة: | Crit Care Resusc. 2020 Jun;22(2):133-141.; 100888170; https://hdl.handle.net/10137/8408Test; Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine; https://www.ezpdhcs.nt.gov.au/login?url=https://www.ncbi.nlm.nih.gov/pubmed/32389105Test |
| الإتاحة: | https://hdl.handle.net/10137/8408Test https://www.ezpdhcs.nt.gov.au/login?url=https://www.ncbi.nlm.nih.gov/pubmed/32389105Test |
| رقم الانضمام: | edsbas.C139C344 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |