Blood Glucose Control With A Software-Algorithm In Intensive Care Unit (ICU) Patients (Aldea _01)

This study has been completed.
Sponsor:
Information provided by:
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT00735163
First received: August 13, 2008
Last updated: April 15, 2009
Last verified: April 2009
  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: 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:


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
Experimental: A
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 of Graz
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Norman Kachel, B. Braun Melsungen AG
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 15, 2014