Study protocol and statistical analysis plan for the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial.
Crit Care Resusc
; 22(2): 133-141, 2020 Jun.
Article
en En
| MEDLINE
| ID: mdl-32389105
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 11 to liberal blood glucose (target 10.0-14.0 mmol/L) or usual care (target 6.0-10.0 mmol/L). MAIN OUTCOMEMEASURES:
The primary endpoint is incident hypoglycaemia (< 4.0 mmol/L) during the study intervention. Secondary endpoints include biochemical and feasibility outcomes. RESULTS ANDCONCLUSION:
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.
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Glucemia
/
Ensayos Clínicos Controlados Aleatorios como Asunto
/
Cuidados Críticos
/
Diabetes Mellitus Tipo 2
/
Protocolos de Ensayos Clínicos como Asunto
Tipo de estudio:
Clinical_trials
/
Guideline
País/Región como asunto:
Oceania
Idioma:
En
Revista:
Crit Care Resusc
Asunto de la revista:
TERAPIA INTENSIVA
Año:
2020
Tipo del documento:
Article