Other Surgical ProceduresContAssGluNCT01580176
Continuous GlucoseMonitor for Measurement of Blood Glucose Level
A study testing continuous GlucoseMonitor in people with Other Surgical Procedures, run by Susanne Frankenhauser at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Other Surgical Procedures
- What is being tested?
- continuous GlucoseMonitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Heidelberg, Department of Anaesthesiology
Heidelberg, D-69120
About this study
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)
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.
Read the 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.
- Conditions
- Other Surgical Procedures
- Being tested
- continuous GlucoseMonitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous GlucoseMonitorDevice
Also called blood glucose examination stand
The blood glucose and blood lactate levels will be taken continuously by the Continuous GlucoseMonitor and will be recorded twelve times.
| Study group | Role | What they receive |
|---|---|---|
| GlucoseMonitor | Experimental | Not described Receives: Device: continuous GlucoseMonitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: eight hours after initial referencing
Secondary outcomes (1)
one and two (short) and three to eight (mid) deterioration
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
Measured: one, two, three, four, five, six, seven and eight hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Frankenhauser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Susanne Frankenhauser, University Hospital Heidelberg
- Investigators
- Johann Motsch, Prof. Dr., Principal investigator, University Hospital Heidelberg, Department of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580176
- Sponsor's protocol ID
- ContAssGlu
- Acronym
- ContAssGlu
- Status last verified
- Dec 2013
- First submitted
- 17 Apr 2012
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22998112
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01580176
- Acronym / sponsor ID
- ContAssGlu / ContAssGlu
- Conditions
- Other Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Susanne FrankenhauserUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GlucoseMonitor | Experimental | Device: continuous GlucoseMonitor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous GlucoseMonitorAlso: blood glucose examination standThe blood glucose and blood lactate levels will be taken continuously by the Continuous GlucoseMonitor and will be recorded twelve times. | Device | GlucoseMonitor |
Primary outcome
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
1 secondary outcome
one and two (short) and three to eight (mid) deterioration
Time frame: one, two, three, four, five, six, seven and eight hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
- Derived from this study: PubMed 22998112Zimmermann 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.
Related trials for Other Surgical Procedures
Active, not recruitingPhase 2
A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung Cancer, NSCLC
Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
RecruitingPhase 3
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
Blood Loss, Surgical, Coagulation Disorder
Not yet recruitingPhase 2
A Study to Assess The Safety and Tolerability of Pumitamig-Based Therapy Administered Before Surgery in Participants With Early-Stage Non-Small Cell Lung Cancer (ROSETTA Lung-220)
Early-Stage Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.
Carcinoma, Hepatocellular, Hepatocellular Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johann Motsch, Prof. Dr. principal investigator
University Hospital Heidelberg, Department of Anaesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous GlucoseMonitor in people with Other Surgical Procedures, run by Susanne Frankenhauser at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eight hours measurement after initial referencing (time frame: eight hours after initial referencing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01580176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2013.