Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit (Aldea_02)
February 4, 2010 updated by: B. Braun Melsungen AG
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom
- Royal Brompton Hospital and Harefield NHS Trust
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: eMPC
improved model predictive control algorithm (eMPC) for glycaemic control in ICU patients
|
eMPC (software on a bedside computer) advised insulin titration to establish tight glycaemic control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
from start of treatment to the last glucose measurement under treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hypoglycemias
Time Frame: from start of treatment to the last glucose measurement under treatment
|
from start of treatment to the last glucose measurement under treatment
|
|
Usability parameters like convenience of alarming function; workload; blood sampling frequency
Time Frame: from start of treatment to the last glucose measurement under treatment
|
from start of treatment to the last glucose measurement under treatment
|
|
Concomitant medication including insulin infusion rate, parenteral/enteral nutrition
Time Frame: from start of treatment to the last glucose measurement under treatment
|
from start of treatment to the last glucose measurement under treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeremy Cordingley, Dr., Royal Brompton & Harefield NHS Foundation Trust
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
April 15, 2009
First Submitted That Met QC Criteria
April 15, 2009
First Posted (Estimate)
April 16, 2009
Study Record Updates
Last Update Posted (Estimate)
February 5, 2010
Last Update Submitted That Met QC Criteria
February 4, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HC-G-H-0807
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.