Study protocol and statistical analysis plan for the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial.
Journal
Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine
ISSN: 1441-2772
Titre abrégé: Crit Care Resusc
Pays: Netherlands
ID NLM: 100888170
Informations de publication
Date de publication:
Jun 2020
Jun 2020
Historique:
entrez:
12
5
2020
pubmed:
12
5
2020
medline:
23
5
2020
Statut:
ppublish
Résumé
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.
Sections du résumé
BACKGROUND
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
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
METHODS
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
METHODS
The primary endpoint is incident hypoglycaemia (< 4.0 mmol/L) during the study intervention. Secondary endpoints include biochemical and feasibility outcomes.
RESULTS AND CONCLUSION
CONCLUSIONS
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
BACKGROUND
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.
Substances chimiques
Blood Glucose
0
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
133-141Références
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
Aust Crit Care. 2019 Nov;32(6):465-470
pubmed: 30591312
Diabetes Care. 2009 Jun;32(6):1119-31
pubmed: 19429873
Lancet. 2005 Feb 19-25;365(9460):711-22
pubmed: 15721478
Crit Care. 2013 Mar 01;17(2):R37
pubmed: 23452622
Crit Care Med. 2009 Dec;37(12):3001-9
pubmed: 19661802
Crit Care Med. 2013 Feb;41(2):580-637
pubmed: 23353941
Diabetes Care. 2006 Aug;29(8):1955-62
pubmed: 16873812
Clin Microbiol Rev. 2006 Oct;19(4):788-802
pubmed: 17041144
Mayo Clin Proc. 2005 Dec;80(12):1558-67
pubmed: 16342648
Crit Care Med. 2016 Sep;44(9):1683-91
pubmed: 27046086
Curr Opin Crit Care. 2019 Aug;25(4):299-306
pubmed: 31246637
Semin Thorac Cardiovasc Surg. 2006 Winter;18(4):317-25
pubmed: 17395028
J Pharmacol Pharmacother. 2010 Jul;1(2):100-7
pubmed: 21350618
Aust Crit Care. 2019 Sep;32(5):361-365
pubmed: 30348487
Crit Care Med. 2008 Aug;36(8):2249-55
pubmed: 18664780
Intensive Care Med. 2011 Mar;37(3):435-43
pubmed: 21210080
Crit Care Med. 2016 Sep;44(9):1695-703
pubmed: 27315191
N Engl J Med. 2008 Jan 10;358(2):125-39
pubmed: 18184958
Intensive Care Med. 2014 Jul;40(7):973-80
pubmed: 24760120
Crit Care Med. 2005 Dec;33(12):2772-7
pubmed: 16352959
Intensive Care Med. 2004 Apr;30(4):536-55
pubmed: 14997291
N Engl J Med. 2001 Nov 8;345(19):1359-67
pubmed: 11794168
Acta Anaesthesiol Scand. 2019 Jul;63(6):761-768
pubmed: 30882892
Crit Care. 2008;12(5):R120
pubmed: 18799004
N Engl J Med. 2018 Nov 08;379(19):1823-1834
pubmed: 30346225
Crit Care Med. 2009 May;37(5):1769-76
pubmed: 19325461
Crit Care Med. 2018 Jun;46(6):935-942
pubmed: 29509570
World J Diabetes. 2015 Jun 10;6(5):693-706
pubmed: 26069718
Intensive Care Med. 2011 Mar;37(3):382-4
pubmed: 21210079
N Engl J Med. 2009 Mar 26;360(13):1283-97
pubmed: 19318384
N Engl J Med. 2012 Sep 20;367(12):1108-18
pubmed: 22992074
Crit Care Med. 2010 Jun;38(6):1430-4
pubmed: 20386307
Crit Care Med. 2008 Dec;36(12):3190-7
pubmed: 18936702
Diabetes. 2006 Nov;55(11):3151-9
pubmed: 17065355