Clinical Risk Assesment of CS-1 Decision Support System

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00502645
First received: July 15, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Hyperglycemia
Critically Ill Patients
Device: CS-1 DECISION SUPPORT SYSTEM

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: April 2007
Study Completion Date: June 2007
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. .

  Eligibility

Ages Eligible for Study:   19 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 > 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)
  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: NCT00502645

Locations
Austria
Medical University Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Thomas R. Pieber, MD Medical University of Graz
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00502645     History of Changes
Other Study ID Numbers: CM10_CS-1
Study First Received: July 15, 2007
Last Updated: July 15, 2007
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
algorithm
cs-1 decision support system
insulin
hyperglycemia
tight glycemic control
intensive care
adults

Additional relevant MeSH terms:
Critical Illness
Hyperglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 11, 2014