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

Sponsor:	B. Braun Melsungen AG
Information provided by:	B. Braun Melsungen AG
ClinicalTrials.gov Identifier:	NCT00735163

Purpose

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.

Condition	Intervention
Critical Illness	Other: enhanced model predictive control algorithm (eMPC)

Study Type:	Interventional
Study Design:	Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:

percentage of time within the predefined glucose target range of 80-110 mg/dL [ Time Frame: from start of treatment to the last glucose measurement under treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

hypoglycemias (lab) and possible attendant clinical symptoms (e.g. convulsions) [ 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:	September 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735163

Locations

Austria
Medical University Graz
Graz, Austria, 8036

Sponsors and Collaborators

B. Braun Melsungen AG

Investigators

Principal Investigator:

Thomas R Pieber, Prof. Dr.

Medical University Graz

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

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. Epub 2008 Feb 23.

Responsible Party:	B. Braun Melsungen AG ( Dr. Norman Kachel )
ClinicalTrials.gov Identifier:	NCT00735163 History of Changes
Other Study ID Numbers:	HC-G-H-0806
Study First Received:	August 13, 2008
Last Updated:	April 15, 2009
Health Authority:	Austria: Ethikkommission

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 September 07, 2010