LOGIC-INSULIN:
Clinical validation and filing for regulatory approval of a blood glucose regulator for the Intensive Care Unit |
Financing: Internal Funding KU Leuven (KU Leuven) Project reference Nr.: IOF/HB/10/039
Description: Critically ill
patients, admitted to the Intensive Care Unit after e.g.
major trauma,cardiac surgery, transplantation or severe infections are in an
imminent life-threatening condition. Criticalillness typically leads to an
increase of the blood glucose concentrations: the so-called stresshyperglycaemia. While stress hyperglycaemia has traditionally been regarded as an
adaptive, beneficialresponse, it has also been clear from observational studies
that hyperglycaemia, as well ashypoglycaemia, are associated with increased
risk of death in critically ill patients. The associationbetween blood glucose
levels and mortality risk follows a J-curved relationship with the nadir
roughlybetween 80-140 mg/dL . The first randomized controlled trial (RCT)
that showed hyperglycaemiaactively contributes to worsened patient outcome was
performed in Leuven. This study targeted a “strictlynormal level for fasting
blood glucose”, i.e. 80-110 mg/dL versus treating hyperglycaemia only when itexceeded
the renal threshold of 215 mg/dL. The insulin dose-adaptations were based on a
guideline tostimulate intuitive and anticipating decision making by bedside
nurses. At the same time the study wasset up with a single-centre,
proof-of-concept design. The latter encompassed precise arterial bloodglucose
measurements with a blood gas analyser and the administration of insulin via an
accuratesyringe pump and a homogeneous patient population (mainly cardiac
surgery and high risk/complicatednon-cardiac surgery). The study showed
that maintaining strict normoglycaemia by “intensive insulintherapy” lowered
ICU mortality from 8.0% to 4.6%and in-hospital mortality from 10.9% to 7.2%.Further,
ICU morbidity was reduced by preventingorgan failure (reflected in a shorter
duration ofmechanical ventilation, a decreased incidence ofacute kidney
failure, severe infections andpolyneuropathy and less blood transfusions).Generalising
to the medical and paediatric critically illpatient population, these results
were confirmed inthe same context of a well controlled, single-centreexpert
setting. SMC people involved in the project:
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