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Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit (Aldea_02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00882427
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : February 5, 2010
Sponsor:
Information provided by:
B. Braun Melsungen AG

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.

Condition or disease Intervention/treatment
Critical Illness Other: enhanced model predictive control algorithm (eMPC)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2009
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Hypoglycemias [ Time Frame: from start of treatment to the last glucose measurement under treatment ]
  2. Usability parameters like convenience of alarming function; workload; blood sampling frequency [ Time Frame: from start of treatment to the last glucose measurement under treatment ]
  3. Concomitant medication including insulin infusion rate, parenteral/enteral nutrition [ Time Frame: from start of treatment to the last glucose measurement under treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 & Harefield NHS Foundation Trust

Publications:
Responsible Party: Dr. Norman Kachel, B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT00882427     History of Changes
Other Study ID Numbers: HC-G-H-0807
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: February 5, 2010
Last Verified: February 2010

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