Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit - Full Text View

Sponsor:	B. Braun Melsungen AG
Information provided by:	B. Braun Melsungen AG
ClinicalTrials.gov Identifier:	NCT00882427

Purpose

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.

Condition	Intervention
Critical Illness	Other: enhanced model predictive control algorithm (eMPC)

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Heart Surgery

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:

percentage of time within the predefined glucose target range of 80-150 mg/dL [ Time Frame: from start of treatment to the last glucose measurement under treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Hypoglycemias [ Time Frame: from start of treatment to the last glucose measurement under treatment ] [ Designated as safety issue: Yes ]
Usability parameters like convenience of alarming function; workload; blood sampling frequency [ Time Frame: from start of treatment to the last glucose measurement under treatment ] [ Designated as safety issue: No ]
Concomitant medication including insulin infusion rate, parenteral/enteral nutrition [ Time Frame: from start of treatment to the last glucose measurement under treatment ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	March 2009
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: eMPC improved model predictive control algorithm (eMPC) for glycaemic control in ICU patients	Other: enhanced model predictive control algorithm (eMPC) eMPC (software on a bedside computer) advised insulin titration to establish tight glycaemic control

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882427

Locations

United Kingdom
Royal Brompton Hospital and Harefield NHS Trust
London, United Kingdom

Sponsors and Collaborators

B. Braun Melsungen AG

Investigators

Principal Investigator:

Jeremy Cordingley, Dr.

Royal Brompton Hospital

More Information

Publications:

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. Epub 2008 Jul 26.

Responsible Party:	Dr. Norman Kachel, B. Braun Melsungen AG
ClinicalTrials.gov Identifier:	NCT00882427 History of Changes
Other Study ID Numbers:	HC-G-H-0807
Study First Received:	April 15, 2009
Last Updated:	February 4, 2010
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by B. Braun Melsungen AG:

algorithm
tight glycemic control
glucose control

intensive care
insulin
ICU

Additional relevant MeSH terms:

Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012