Continuous GlucoseMonitor for Measurement of Blood Glucose Level

NCT01580176 | Completed

• 1 other identifier: ContAssGlu
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Other Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Eight hours measurement 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

  eight hours after initial referencing

Secondary Outcomes (1)

• one and two (short) and three to eight (mid) deterioration

  one, two, three, four, five, six, seven and eight hours

Study Arms (1)

GlucoseMonitor

EXPERIMENTAL

Device: continuous GlucoseMonitor

Interventions

continuous GlucoseMonitor DEVICE

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

Also known as: blood glucose examination stand

GlucoseMonitor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Susanne Frankenhauser: lead

Study Sites (1)

University Hospital Heidelberg, Department of Anaesthesiology

Heidelberg, D-69120, Germany

Location

Related Publications (1)

• Zimmermann JB, Lehmann M, Hofer S, Husing J, Alles C, Werner J, Stiller J, Kunnecke W, Luntz S, Motsch J, Weigand MA. Design of a prospective clinical study on the agreement between the Continuous GlucoseMonitor, a novel device for CONTinuous ASSessment of blood GLUcose levels, and the RAPIDLab(R) 1265 blood gas analyser: The CONTASSGLU study. BMC Anesthesiol. 2012 Sep 22;12:24. doi: 10.1186/1471-2253-12-24.

  PMID: 22998112 DERIVED

Study Officials

• Johann Motsch, Prof. Dr.

  University Hospital Heidelberg, Department of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Susanne Frankenhauser

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: April 18, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

DE (1)