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Correlation Between the Interstitial and Arterial Glucose in Post Surgery Patients

NCT ID: NCT00733148

Last Updated: 2008-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-04-30

Brief Summary

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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

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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.

Conditions

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Intensive Care

Keywords

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glucose, interstitial, intensive care

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Routine Care

dosing of insulin

Intervention Type DRUG

Dosing od insulin is calculated by a computer based algorithm

2

Insulin infusion based on model predictive algorithm (MPC)

dosing of insulin

Intervention Type DRUG

Dosing od insulin is calculated by a computer based algorithm

Interventions

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dosing of insulin

Dosing od insulin is calculated by a computer based algorithm

Intervention Type DRUG

Other Intervention Names

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Model predictive control

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent obtained before any trial-related activities.
* Planned surgery and post-surgery stay in the ICU.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Graz

Principal Investigators

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Thomas R. Pieber, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University Graz

Graz, Styria, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 21284479 (View on PubMed)

Other Identifiers

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CM1

Identifier Type: -

Identifier Source: org_study_id