Back to resultsBlood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit (Aldea_02)
Primary Purpose
Critical Illness
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
enhanced model predictive control algorithm (eMPC)
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring algorithm, tight glycemic control, glucose control, intensive care, insulin, ICU
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)
Sites / Locations
- Royal Brompton Hospital and Harefield NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
eMPC
Arm Description
improved model predictive control algorithm (eMPC) for glycaemic control in ICU patients
Outcomes
Primary Outcome Measures
percentage of time within the predefined glucose target range of 80-150 mg/dL
Secondary Outcome Measures
Hypoglycemias
Usability parameters like convenience of alarming function; workload; blood sampling frequency
Concomitant medication including insulin infusion rate, parenteral/enteral nutrition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00882427
Brief Title
Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit
Acronym
Aldea_02
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
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
B. Braun Melsungen AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
algorithm, tight glycemic control, glucose control, intensive care, insulin, ICU
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eMPC
Arm Type
Experimental
Arm Description
improved model predictive control algorithm (eMPC) for glycaemic control in ICU patients
Intervention Type
Other
Intervention Name(s)
enhanced model predictive control algorithm (eMPC)
Intervention Description
eMPC (software on a bedside computer) advised insulin titration to establish tight glycaemic control
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Hypoglycemias
Time Frame
from start of treatment to the last glucose measurement under treatment
Title
Usability parameters like convenience of alarming function; workload; blood sampling frequency
Time Frame
from start of treatment to the last glucose measurement under treatment
Title
Concomitant medication including insulin infusion rate, parenteral/enteral nutrition
Time Frame
from start of treatment to the last glucose measurement under treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Cordingley, Dr.
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton Hospital and Harefield NHS Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
18661120
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.
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Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit
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