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

This study has been completed.
Sponsor:
Information provided by:
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT00882427
First received: April 15, 2009
Last updated: February 4, 2010
Last verified: February 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 25, 2014