Tight Glycemic Control by eMPC Algorithm in Medical ICU Patients.
An Open, Mono-Centre Randomised Controlled Trial to Investigate the Feasibility of Blood Glucose Control With the Software-Algorithm eMPC (Enhanced Model Predictive Control) Via the Arterial-Intravenous Route in Patients at the Medical Intensive Care Unit.
1 other identifier
interventional
50
1 country
1
Brief Summary
This is an open mono-centre randomised controlled trial performed at the Medical University Graz including a treatment visit (V1). In the treatment visit (V1) after admittance to the ICU arterial blood glucose values will be monitored and either the software-algorithm eMPC will be used to adjust the infusion rate of intravenously administered human soluble insulin to normalise arterial blood glucose or routine treatment will be used to establish tight glycaemic control. The treatment visit will last for 72 hours. The primary hypothesis of the study is that blood glucose control by the eMPC algorithm is not inferior compared to the implemented routine protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2006
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 12, 2007
CompletedFirst Posted
Study publicly available on registry
April 13, 2007
CompletedApril 13, 2007
April 1, 2007
April 12, 2007
April 12, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hyperglycemic Index
Secondary Outcomes (4)
Number of hypoglycaemic episodes (BG < 40 mg/dl (< 2.2mM) [10] )
Mean glucose
Sampling interval
Insulin need
Interventions
Eligibility Criteria
You may qualify if:
- Mechanical ventilation
- Increased blood glucose levels during ICU care (\> 110 mg/dL; \> 6.1 mM) or patient on current insulin treatment.
- Age of patients in the range from 18 to 90 years.
You may not qualify if:
- Known or suspected allergy against insulin.
- Any disease or condition which the Investigator or the treating physician feels would interfere with the trial or the safety of the patient.
- Patients participating in another study.
- Moribund patients likely to die in the next 24 hours.
- Disabled patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University Graz
Graz, 8036, Austria
Related Publications (1)
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. doi: 10.2337/diacare.29.02.06.dc05-1689.
PMID: 16443872BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas R Pieber, MD.
Medical University of Graz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 12, 2007
First Posted
April 13, 2007
Study Start
May 1, 2006
Study Completion
November 1, 2006
Last Updated
April 13, 2007
Record last verified: 2007-04