Clinical Risk Assesment of CS-1 Decision Support System

NCT00502645 | Completed

• 1 other identifier: CM10_CS-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open, non-controlled clinical investigation in 10 patients at the Medical University Graz including a treatment visit (V1)and a follow up visit(V2). 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. The purpose of the present study is to investigate the performance of the already developed and tested algorithm in combination with a newly developed bed-side, touch screen user interface (CS-1 decision support system) in patients at the medical ICU for a period of 72 hours. Follow up information(V2) will be acquired at hospital discharge or at the latest one week after visit 1.

Conditions

Hyperglycemia; Critically Ill Patients

Keywords

algorithm; cs-1 decision support system; insulin; hyperglycemia; tight glycemic control; intensive care; adults

Outcome Measures

Primary Outcomes (1)

• Percentage of time within predefined glucose target range 80-110mg/dL

  Start: Start of treatment ; End: Last glucose measurement under treatment

Secondary Outcomes (1)

• Hypoglycemias (<40mg/dl =2,2mM); Blood sampling frequency as adviced by device; Malfunctions of device Relevant-medication, nutrition; Insulin Infusion Rate; Blood glucose values; Handling/ usability of device;

  Start: Start of treatment, End: Last glucose measurement under treatment

Interventions

CS-1 DECISION SUPPORT SYSTEM DEVICE

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: \> 18 years of age
• Stay in the ICU expected to be \> 72 h
• Blood glucose \> 110 mg/dl or patient on insulin treatment

You may not qualify if:

• 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)
• Patients participating in another study
• Moribund patients likely to die within 24 hours
• Patients after organ transplantation within the last three months
• Patients under high dose cortisol treatment (cortisol \> 1000 mg/day or equivalent dosis of hydrocortisol)

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, 8036, Austria

Location

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: 16443872 BACKGROUND

MeSH Terms

Conditions

Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Officials

• Thomas R. Pieber, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 15, 2007
• First Posted: July 17, 2007
• Study Start: April 1, 2007
• Study Completion: June 1, 2007
• Last Updated: July 17, 2007

Record last verified: 2007-07

Locations

AU (1)