Correlation Between the Interstitial and Arterial Glucose in Post Surgery Patients

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00733148
First received: August 7, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted

August 7, 2008
August 7, 2008
July 2004
January 2005   (final data collection date for primary outcome measure)
Time concentration profiles of arterial blood glucose concentrations and interstitial fluid glucose concentrations [ Time Frame: hourly ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Prospectively calibrated interstitial fluid glucose concentration profiles [ Time Frame: hourly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Correlation Between the Interstitial and Arterial Glucose in Post Surgery Patients
Randomised Trial to Investigate the Correlation Between the Interstitial and Arterial Blood Concentrations of Glucose During Subcutaneous Microdialysis Glucose Monitoring in Post Surgery Patients at the Intensive Care Unit.

The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients) aims to develop a low-risk monitoring and control device which allows maintaining metabolic control in intensive care units. A system will be developed comprising three subsystems: a body interface for the delivery of biofluids, biosensors for the determination of glucose concentration in these biofluids and an adaptive control algorithm that generates advice and thus represents a decision support system with respect to insulin infusion rate to establish glycaemic control in critically ill patients. Within a closed loop system, intensified insulin treatment will make use of the calculations leading to external regulation of glucose.

It is the aim of this study to evaluate the correlation between arterial blood glucose concentrations and interstitial fluid glucose concentrations in post surgery patients in the Intensive Care Unit (ICU). Interstitial fluid glucose concentrations are based on microdialysis in subcutaneous adipose tissue and calculated using the ionic reference technique.

This trial includes a screening visit (V1) and a monitoring visit (V2) and follow-up assessment. Visit 1 will be performed before performance of surgery to obtain informed consent and to assess patient eligibility. At Visit 2 monitoring visit after surgery) arterial blood glucose values will be monitored and subcutaneous sampling of ISF with microdialysis for glucose determination will be performed. Visit 2 will last from admittance to the ICU for 48 hours. In a follow-up assessment, two weeks after the end of visit 2, further clinical relevant data for the two week period after visit 2 will be collected.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Patients with a blood glucose level of more than 120 mg/dl (6.7mM) at admission to the ICU after surgery

Intensive Care
Drug: dosing of insulin
Dosing od insulin is calculated by a computer based algorithm
Other Name: Model predictive control
  • 1
    Routine Care
    Intervention: Drug: dosing of insulin
  • 2
    Insulin infusion based on model predictive algorithm (MPC)
    Intervention: Drug: dosing of insulin
Schaupp L, Plank J, Köhler G, Schaller R, Wrighton C, Ellmerer M, Pieber TR. Prediction of glucose concentration in post-cardiothoracic surgery patients using continuous glucose monitoring. Diabetes Technol Ther. 2011 Feb;13(2):127-34. doi: 10.1089/dia.2010.0117.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2005
January 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent obtained before any trial-related activities.
  • Planned surgery and post-surgery stay in the ICU.
  • Study day inclusion criteria: Increased blood glucose levels at admission to the ICU ( > 120 mg/dL; > 6.7 mM)
  • Age of patients in the range from 18 to 90 years.

Exclusion Criteria:

  • Known or suspected allergy against insulins.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
  • Any disease or condition which the Investigator or the treating physician feels would interfere with the trial or the safety of the patient.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00733148
CM1
Yes
Thomas R. Pieber, Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Thomas R. Pieber, MD Medical University of Graz
Medical University of Graz
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP