Correlation Between the Interstitial and Arterial Glucose in Post Surgery Patients

NCT00733148 | Completed DMC

• 1 other identifier: CM1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care

Keywords

glucose, interstitial, intensive care

Outcome Measures

Primary Outcomes (1)

• Time concentration profiles of arterial blood glucose concentrations and interstitial fluid glucose concentrations

  hourly

Secondary Outcomes (1)

• Prospectively calibrated interstitial fluid glucose concentration profiles

  hourly

Study Arms (2)

1

Routine Care

Drug: dosing of insulin

2

Insulin infusion based on model predictive algorithm (MPC)

Drug: dosing of insulin

Interventions

dosing of insulin DRUG

Dosing od insulin is calculated by a computer based algorithm

Also known as: Model predictive control

1; 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, Styria, A8036, Austria

Location

Related Publications (1)

• 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.

  PMID: 21284479 DERIVED

Study Officials

• Thomas R. Pieber, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 12, 2008
• Study Start: July 1, 2004
• Primary Completion: January 1, 2005
• Study Completion: April 1, 2005
• Last Updated: August 12, 2008

Record last verified: 2008-08

Locations

AU (1)