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Completed

NCT Number: NCT01580176

Continuous GlucoseMonitor for Measurement of Blood Glucose Level

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Heidelberg, Department of Anaesthesiology

Heidelberg, D-69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

continuous GlucoseMonitor

Device

The blood glucose and blood lactate levels will be taken continuously by the Continuous GlucoseMonitor and will be recorded twelve times.

Other names: blood glucose examination stand

Primary outcomes

  1. Eight hours measurement after initial referencing

    Time frame: eight hours after initial referencing

    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 outcomes

  1. one and two (short) and three to eight (mid) deterioration

    Time frame: one, two, three, four, five, six, seven and eight hours

    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

Sponsors and collaborators

Lead sponsor

Susanne Frankenhauser

Other

Registry information

Official study 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)

Acronym: ContAssGlu

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 18, 2012
Registry last updated
Dec 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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