Clinical trial NCT00882427: Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit
Official title: Single-center, Open Study on the Performance of the Software eMPC Algorithm Used for Blood Glucose Control Over an Extended Glucose Control Range (4.4 to 8.3 mmol/L) for a Maximum of 48 Hours in Postoperative Cardiac Surgery Patients in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: algorithm
tight glycemic control
glucose control
intensive care
insulin
ICU
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated that tight blood glucose control in medical and surgical ICU patients results in a significant better outcome for the patients. Based on this emerging clinical evidence, there are increasing efforts worldwide to maintain strict glycaemic control in critically ill patients. However, achieving this goal requires extensive nursing efforts, including frequent bedside glucose monitoring and the implementation of complex intensive insulin infusion protocols. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. This study will investigate the performance of an eMPC algorithm adjusted to target the range 4.4 - 8.3 mmol/L in line with the Surviving Sepsis guidelines.


Eligibility criteria: Inclusion Criteria:

* Age: \> 18 years of age
* Admitted following cardiac surgery
* Stay in the ICU expected to be \> 20h
* Blood glucose \> 6.7 mmol/l within 4 hours of admission to intensive care or patient already receiving insulin treatment

Exclusion Criteria:

* Patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
* Known or suspected allergy to insulin
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e. liver failure, other fatal organ failures)
* Patients participating in another study
* Moribund patients likely to die within 24 hours
* Patients after organ transplantation within the last three months
* Patients under high dose cortisol treatment (cortisol \> 1000 mg/day or equivalent doses of hydrocortisol)

Primary outcomes:
measure: percentage of time within the predefined glucose target range of 80-150 mg/dL
timeFrame: from start of treatment to the last glucose measurement under treatment
Secondary outcomes:
measure: Hypoglycemias
timeFrame: from start of treatment to the last glucose measurement under treatment
measure: Usability parameters like convenience of alarming function; workload; blood sampling frequency
timeFrame: from start of treatment to the last glucose measurement under treatment
measure: Concomitant medication including insulin infusion rate, parenteral/enteral nutrition
timeFrame: from start of treatment to the last glucose measurement under treatment
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital and Harefield NHS Trust
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Jeremy Cordingley, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cordingley JJ, Vlasselaers D, Dormand NC, Wouters PJ, Squire SD, Chassin LJ, Wilinska ME, Morgan CJ, Hovorka R, Van den Berghe G. Intensive insulin therapy: enhanced Model Predictive Control algorithm versus standard care. Intensive Care Med. 2009 Jan;35(1):123-8. doi: 10.1007/s00134-008-1236-z. Epub 2008 Jul 26.