Clinical trial NCT00733148: Correlation Between the Interstitial and Arterial Glucose in Post Surgery Patients
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care
Keywords: glucose, interstitial, intensive care
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2008-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time concentration profiles of arterial blood glucose concentrations and interstitial fluid glucose concentrations
timeFrame: hourly
Secondary outcomes:
measure: Prospectively calibrated interstitial fluid glucose concentration profiles
timeFrame: hourly
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Thomas R. Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.