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

Critical Illness Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882427
• Other study ID #: HC-G-H-0807
• Status: Completed
• Phase: N/A
• First received: April 15, 2009
• Last updated: February 4, 2010
• Start date: March 2009
• Est. completion date: July 2009

Study information

• Verified date: February 2010
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• enhanced model predictive control algorithm (eMPC)
eMPC (software on a bedside computer) advised insulin titration to establish tight glycaemic control

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital and Harefield NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of time within the predefined glucose target range of 80-150 mg/dL		from start of treatment to the last glucose measurement under treatment	Yes
Secondary	Hypoglycemias		from start of treatment to the last glucose measurement under treatment	Yes
Secondary	Usability parameters like convenience of alarming function; workload; blood sampling frequency		from start of treatment to the last glucose measurement under treatment	No
Secondary	Concomitant medication including insulin infusion rate, parenteral/enteral nutrition		from start of treatment to the last glucose measurement under treatment	No