Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Hyperglycaemia is commonly found in critically ill patients. The stress of critical illness induces glucose counterregulatory hormones and a number of alterations in carbohydrate metabolism, including increased peripheral glucose demands, enhanced hepatic glucose production, insulin resistance and relative insulin deficiency. Moreover, clinical interventions, such as corticoids, vasopressors, and enteral or parenteral nutrition, further predispose these patients to elevated blood glucose levels. In patients in intensive care as well as in general hospital settings patients with hyperglycemia have higher mortality rates. Recent studies demonstrated that tight blood glucose control in ICU patients results in a significant better outcome for the patients.

Based on this emerging clinical evidence, there are increasing efforts world-wide 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 and such increased work demands may not be readily accepted by a busy ICU nursing staff.

The development of a closed loop control system that automatically infuses insulin on the basis of glucose measurements could permit strict glycaemic control and improve clinical outcome without increasing workload of the ICU nursing staff. The EU founded project CLINICIP (Closed Loop Infusion in Critically ill patients) aims to develop a low–risk monitoring and control system which allows maintaining metabolic control in intensive care units. As a first step a local bedside semi-closed system will be developed. Based on arterial spot measurement, an adaptive control algorithm will generate advice and thus represent a decision supporting system for the ICU nursing staff. This control algorithm was adapted for patients in the ICU. The first study using this algorithm was performed at the Medical University Hospital in Graz. In all six patients, who were included in this feasibility trial, blood glucose levels could be normalised and maintained in the narrow target range for up to 24 hours without a single hypoglycaemic episode. Subsequently, the algorithm was tested in a multicentric randomized controlled trial setting and showed superiority by means of a reduced number of hypoglycaemic events and a higher percentage of glucose values within the target range as compared to routine care glucose management protocols. In this study it was a fact that the hourly sampling frequency in the algorithm group has positively influenced the outcome in the algorithm group. Therefore in an enhanced version of the algorithm (eMPC) the sampling interval is expanded up to 240 min.

The purpose of this study is to evaluate the feasibility of this enhanced model predictive control algorithm for glycaemic control in critically ill patients compared to routine treatment. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00460252
Study type Interventional
Source Medical University of Graz
Contact
Status Completed
Phase N/A
Start date May 2006
Completion date November 2006

See also
  Status Clinical Trial Phase
Completed NCT01267448 - Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia Phase 4
Recruiting NCT03775733 - Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia N/A
Completed NCT03482154 - Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
Active, not recruiting NCT05477368 - Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes N/A
Completed NCT03675360 - Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial N/A
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin
Not yet recruiting NCT06159543 - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes N/A
Recruiting NCT02885922 - The Effects of add-on Anti-diabetic Drugs in Type 2 Diabetic Patients
Recruiting NCT02885909 - Inpatient Blood Glucose Control in Taichung Veterans General Hospital Phase 4
Completed NCT02012465 - Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Patients Early Phase 1
Withdrawn NCT01488383 - Effect of Stevioside in Postpandrial Glucose in Healthy Adults N/A
Completed NCT01805414 - Breakfast Nutrition and Inpatient Glycemia N/A
Completed NCT01803568 - Skeletal Muscles, Myokines and Glucose Metabolism MYOGLU N/A
Completed NCT01810952 - The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients Phase 4
Active, not recruiting NCT01247714 - Clinical Evaluation of a Specific Enteral Diet for Diabetics N/A
Not yet recruiting NCT00846144 - The Reduction in Glucose Stimulated Insulin Secretion Induced by Cytokines May be Prevented by Copper Addition - Studies in Diabetic Patients N/A
Completed NCT00996099 - Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients N/A
Recruiting NCT00654797 - Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2 Phase 2
Completed NCT00468494 - Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia? N/A
Completed NCT00394407 - Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes Phase 4