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.

Study Overview

• Status: Completed
• Conditions: Intensive Care
• Intervention / Treatment: Drug: dosing of insulin

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, A8036
      • Medical University Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Routine Care	Drug: dosing of insulin; Dosing od insulin is calculated by a computer based algorithm; Other Names: Model predictive control
2; Insulin infusion based on model predictive algorithm (MPC)	Drug: dosing of insulin; Dosing od insulin is calculated by a computer based algorithm; Other Names: Model predictive control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time concentration profiles of arterial blood glucose concentrations and interstitial fluid glucose concentrations	hourly

Secondary Outcome Measures

Outcome Measure	Time Frame
Prospectively calibrated interstitial fluid glucose concentration profiles	hourly

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Schaupp L, Plank J, Kohler 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): January 1, 2005
• Study Completion (Actual): April 1, 2005

Study Registration Dates

• First Submitted: August 7, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (Estimate): August 12, 2008

Study Record Updates

• Last Update Posted (Estimate): August 12, 2008
• Last Update Submitted That Met QC Criteria: August 7, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: glucose, interstitial, intensive care
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: CM1