Blood Glucose Control With A Software-Algorithm In Intensive Care Unit (ICU) Patients

Critical Illness Clinical Trial

— Aldea _01  

Official title:

Mono-Centric, Open, Non-Controlled Study To Investigate The Feasibility Of Blood Glucose Control With The Software-Algorithm eMPC (Enhanced Model Predictive Control) In ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735163
• Other study ID #: HC-G-H-0806
• Status: Completed
• Phase: N/A
• First received: August 13, 2008
• Last updated: April 15, 2009
• Start date: September 2008
• Est. completion date: February 2009

Study information

• Verified date: April 2009
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Recently, large randomized controlled trials have demonstrated that tight glycaemic control (TGC) reduces morbidity and mortality in this population. Based on this emerging evidence intensive insulin therapy is currently finding its way into the critical care practice.

In the meantime numerous insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented. Recent reviews comparing different types of protocols describe widely ranging practice and difficulties in achieving TGC despite extensive efforts of the intensive care unit (ICU) staff. 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. The primary objective of the current study is to investigate the performance (efficacy) of a control algorithm for glycaemic control in ICU patients for the whole length of ICU stay.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Age: > 18 years of age

• Stay in the ICU expected to be > 120 h

• Blood glucose > 110 mg/dl or patient on 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)

• Moribund patients likely to die within 24 hours

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
Austria	Medical University Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Pachler C, Plank J, Weinhandl H, Chassin LJ, Wilinska ME, Kulnik R, Kaufmann P, Smolle KH, Pilger E, Pieber TR, Ellmerer M, Hovorka R. Tight glycaemic control by an automated algorithm with time-variant sampling in medical ICU patients. Intensive Care Med. 2008 Jul;34(7):1224-30. doi: 10.1007/s00134-008-1033-8. Epub 2008 Feb 23. — View Citation

Plank J, Blaha J, Cordingley J, Wilinska ME, Chassin LJ, Morgan C, Squire S, Haluzik M, Kremen J, Svacina S, Toller W, Plasnik A, Ellmerer M, Hovorka R, Pieber TR. Multicentric, randomized, controlled trial to evaluate blood glucose control by the model predictive control algorithm versus routine glucose management protocols in intensive care unit patients. Diabetes Care. 2006 Feb;29(2):271-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of time within the predefined glucose target range of 80-110 mg/dL		from start of treatment to the last glucose measurement under treatment	Yes
Secondary	hypoglycemias (lab) and possible attendant clinical symptoms (e.g. convulsions)		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