KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

Conditions

Critical Illness

Keywords

critical illness, intensive care, outcome, insulin, blood glucose

Brief summary

In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.

Detailed description

In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.

Boonen E, Vervenne H, Meersseman P, Andrew R, Mortier L, Declercq PE, Vanwijngaerden YM, Spriet I, Wouters PJ, Vander Perre S, Langouche L, Vanhorebeek I, Walker BR, Van den Berghe G.

2013-03-19309 citations

10.1056/nejmoa1214969

Intensive insulin therapy in the medical ICU.

Van den Berghe G, Wilmer A, Hermans G, Meersseman W, Wouters PJ, Milants I, Van Wijngaerden E, Bobbaers H, Bouillon R.

2006-02-012,182 citations

10.1056/nejmoa052521

Interventions

DRUGintensive insulin therapy to maintain normoglycemia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Adults admitted to ICU and anticipated to require intensive care for at least a few days

Exclusion criteria

* Expected short ICU stay * Therapy restricted upon admission * Surgical ICU patients * Other studies * Below 18 years * Pregnancy

Design outcomes

Primary

Measure	Time frame
mortality	—

Secondary

Measure	Time frame
stay in Intensive Care Unit (ICU)	—
stay in hospital	—
mechanical ventilatory support-dependency	—
morbidity	—
a long-term follow up is planned to take place 6 and 12 months after hospital discharge	—
organ failure	—

Countries

Belgium

Outcome results

None listed