Clinical Risk Assesment of CS-1 Decision Support System

July 15, 2007 updated by: Medical University of Graz

SINGLE-CENTER,OPEN,NON-CONTROLLED FEASIBILITY STUDY ON THE PERFORMANCE OF THE CS-1 DECISION SUPPORT SYSTEM WITH INCORPORATED SOFTWARE-ALGORITHM eMPC USED FOR BLOOD GLUCOSE CONTROL OVER 72 HOURS IN CRITICALLY ILL PATIENTS AT THE INTENSIVE CARE UNIT

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before the beginning of any trial related activities, the relatives of each patient will be asked if the patient has ever mentioned in the past, that he/she does not want do participate in any kind of clinical study. If this was said by the patient in the past or if there are any signs which make it likely that the patient would not participate, he/she will be excluded from the trial. After testing of the inclusion and exclusion criteria, screening information will be obtained a the beginning of the trial. A screening number will be assigned to the patient in ascending order. The following data will be recorded in the case record form (CRF): Check for inclusion/exclusion criteria,demographic data, medical (including diabetes) history and relevant medication, body weight and heightand laboratory analyses from routine laboratory assessment. Patients fulfilling all the inclusion criteria and none of the exclusion criteria will be included into the trial and a subject number will be assigned in ascending order. Routine intensive care will be provided from department of internal medicine. Trial related activities will not interfere with regular patient care. Blood samples will be retrieved from an arterial line, available for routine diagnostic and monitoring procedures in all patients. At time 0, a blood glucose measurement will be taken, manually entered into the CS-1 decision support system and both a insulin infusion rate and the time to next glucose reading will be suggested by the computer-based system. Based on the suggestion of the system, an insulin infusion pump as routinely used in the ICU will be manually set to this suggested insulin infusion rate by specially trained ICU staff but only if the staff feels safe with this suggestion. Intravenous infusion of human soluble insulin will then be started. For safety reasons: In case that the suggested measurement interval of the decision support system exceeds a 90 minute interval, interim glucose measurements will be taken. All measurements will be documented in the CRF. Only in case that the blood glucose values are below 40 mg/dl the additional interim-glucose value will also be put into the CS-1 system. However, the nursing staff can at any time decide to take an additionlal blood glucose measurement and/or neglect the decision as suggested by the system.

The target range for blood glucose levels will be 80-110 mg/dl [4.4 - 6.1 mmol/l]. The current blood glucose level and insulin infusion rate will continuously be documented by the CS-1 decision support system and supervised by the investigator. Glucose values will be provided to the system by manual entry. In case of hypoglycaemia, intravenous insulin infusion will be stopped and glucose will be administered via intravenous bolus.

The treatment visit, including all trial related activities as described above, will last for 72 hours. Adverse events and relevant medication will be continuously monitored and documented The Acute Physiology and Chronic Health Evaluation Score (Apache II) will be documented for each patient at the beginning of the trial. There is no physical connection between the algorithm suggesting the insulin infusion rate and the insulin infusion pump such as that the algorithm would be capable to independently steer the insulin infusion. There is also no physical connection between the glucose measurement device and the algorithm such as that the algorihthm would be able to independently get a glucose measurement. For safety reasons, both the glucose measurement and the insulin infusion rate are parameters that need to be manually entered by a specially trained nurse. For glucose measurement, a certified device for ICU application is being used (Accuchek® Inform; Roche Diagnostics), for intravenous insulin infusion, a certified insulin infusion pump (Perfusor® Space, BBraun Melsungen) as it is used under routine conditions in the ICU is being used. Follow up information will be acquired at hospital discharge or at the latest one week after visit 1. .

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: > 18 years of age
  • Stay in the ICU expected to be > 72 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)
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time within predefined glucose target range 80-110mg/dL
Time Frame: Start: Start of treatment ; End: Last glucose measurement under treatment
Start: Start of treatment ; End: Last glucose measurement under treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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;
Time Frame: Start: Start of treatment, End: Last glucose measurement under treatment
Start: Start of treatment, End: Last glucose measurement under treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Thomas R. Pieber, MD, Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

July 15, 2007

First Submitted That Met QC Criteria

July 15, 2007

First Posted (Estimate)

July 17, 2007

Study Record Updates

Last Update Posted (Estimate)

July 17, 2007

Last Update Submitted That Met QC Criteria

July 15, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM10_CS-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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