Continuous GlucoseMonitor for Measurement of Blood Glucose Level (ContAssGlu)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Susanne Frankenhauser, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01580176
First received: April 17, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

This study will be the first study in which the new central venous microdialysis-based continuous glucose monitoring system (Continuous GlucoseMonitor) is used to investigate the performance of this Continuous GlucoseMonitor, as the measurements will be compared with a point of care reference (RAPIDLab® 1265 blood gas analyser). Further important points are also much less blood samplings / blood loss for the patient and personnel costs.


Condition Intervention
Other Surgical Procedures
Device: continuous GlucoseMonitor

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Prospective Clinical Trial on Agreement to Evaluate the GlucoseMonitor, a Novel Device for Continuous Assessment of Blood Glucose Levels, in Comparison With the RAPIDLab® 1265 Blood Gas Analyser (ContAssGlu)

Resource links provided by NLM:


Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Eight hours measurement after initial referencing [ Time Frame: eight hours after initial referencing ] [ Designated as safety issue: Yes ]
    Agreement at point of care, i.e. agreement between the readings from the Continuous GlucoseMonitor taken eight hours after initial referencing and the measurement results from the RAPIDLab® 1265 blood gas analyser taken at the same time


Secondary Outcome Measures:
  • one and two (short) and three to eight (mid) deterioration [ Time Frame: one, two, three, four, five, six, seven and eight hours ] [ Designated as safety issue: Yes ]
    Short (one and two hour) and mid term (three to eight hour) deterioration in agreement, i.e. agreement between the readings from the Continuous GlucoseMonitor taken one and two and three, four, five, six, seven as well as eight hours after initial referencing and the measurement results from the RAPIDLab® 1265 blood gas analyser taken at the same time


Enrollment: 100
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GlucoseMonitor Device: continuous GlucoseMonitor
The blood glucose and blood lactate levels will be taken continuously by the Continuous GlucoseMonitor and will be recorded twelve times.
Other Name: blood glucose examination stand

Detailed Description:

The current standard for measuring blood glucose concentrations on ICU is to manually draw a blood sample from an arterial catheter and analyse the sample using a point of care blood gas analyser. This technique has several disadvantages as causes considerable blood loss and does not produce a continuous blood glucose profile and it is labour intensive (multiple samples over time are needed to follow the changes in blood glucose concentration). The monitoring system (Continuous GlucoseMonitor) based on the microdialysis technique has the advantage that not blood, but a physiological fluid such as saline is used as test medium. In brief, a physiological fluid, called the perfusate is continuously perfused through the microdialysis probe. At the membrane of the probe, glucose (as other low-molecular weight molecules) diffuses from the surrounding sample into the perfusate, now called dialysate, and is transported outside the probe for ex vivo monitoring.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • having undergone major abdominal and predominantly pancreatic surgery due to any reason
  • expected to be in intensive care for at least 8 hours following index surgery
  • need for close monitoring of blood glucose levels postoperatively
  • having received a two-lumen central venous catheter for anaesthesia and operative purposes
  • antibiotic prophylaxis (e.g. mezlocillin 4.0g and metronidazole 500mg)
  • received routine perioperative thromboembolic prophylaxis medication (e.g. low-molecular-weight-heparin, heparin)
  • aged at least 18 up to 80 years
  • Capable of giving informed consent (written informed consent, signed and dated)
  • successful central venous catheter in place (at least double lumen)
  • one lumen of the central venous catheter will not be used postoperatively for routine infusion therapy and routine application of medications

Exclusion Criteria:

  • known history of thrombosis, embolism; vascular obliteration
  • known bleeding disorders, e.g. thrombocytosis
  • known history of acute or chronic renal failure and patients on renal replacement therapy (dialysis, hemofiltration)
  • known history of acute or chronic heart failure
  • evidence of acute postoperative hyperhydration (pulmonary congestion)
  • known history of acquired immune deficiency syndrome
  • patients receiving immune suppressive therapy
  • any signs for acute or chronic infection
  • contraindication for insertion of a central venous catheter
  • contraindication for perioperative thromboembolic prophylaxis medication (e.g. low-molecular-weight-heparin, heparin)
  • exceedance the flushing infusion volume (500 mL per 24 hours)
  • pregnancy and lactation
  • Participation in another parallel clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580176

Locations
Germany
University Hospital Heidelberg, Department of Anaesthesiology
Heidelberg, Germany, D-69120
Sponsors and Collaborators
Susanne Frankenhauser
Investigators
Principal Investigator: Johann Motsch, Prof. Dr. University Hospital Heidelberg, Department of Anaesthesiology
  More Information

No publications provided

Responsible Party: Susanne Frankenhauser, Dr. Susanne Frankenhauser, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01580176     History of Changes
Other Study ID Numbers: ContAssGlu
Study First Received: April 17, 2012
Last Updated: December 19, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on August 28, 2014