Intensive Care PatientsNCT01523665
Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System
An observational study of Intensive Care Patients, run by B. Braun Melsungen AG at 17 sites in 9 countries.
Trial summary
Glucose metabolism is impaired in many critically ill patients and is often aggravated by parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented on most critical care units. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intensive Care Patients
- How many people
- 508 participants
- Where
- 17 sitesin 9 countries
- Study dates
- Oct 2011to Jul 2013
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: adult patients
Who may be able to join
- Intensive care patients who require blood glucose control by intravenous application of insulin
Who cannot join
- All contraindication of intravenous insulin therapy
Trial locations and contacts
17 sites in 9 countries.
17 sites in 9 countries
Czechia3 sites
Investigational Site
Hradec Králové
Investigational Site
Pilsen
Investigational sites
Prague
Sweden3 sites
Investigational Site
Jönköping
Investigational Site
Södertälje
Investigational Site
Stockholm
United Kingdom2 sites
West Suffolk Hospital
Bury Saint Edmonds
Royal Cornwall Hospital
Truro
About this study
Official title: Evaluation of Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System
Glucose metabolism is impaired in many critically ill patients and is often aggravated by parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented on most critical care units. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. Several barriers to the implementation of glycemic control have been identified. Most importantly, there is concern about increased frequency of severe hypoglycemic episodes. To overcome these problems Space GlucoseControl was developed as a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges (4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l).
The objective of this non-interventional study is to gain additional information on the performance of the Space GlucoseControl system for glycaemic control in ICU patients when used in routine clinical practice.
- Conditions
- Intensive Care Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose values: Percentage of time within the chosen glucose target range of 4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l
Measured: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
Secondary outcomes (3)
Frequency of hypoglycaemic episodes
Measured: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
Adherence to the advice of the Space GlucoseControl system
Measured: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
Blood glucose measurement interval
Measured: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionJul 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 Intensive Care PatientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523665
- Sponsor's protocol ID
- HC-O-H-1102
- Status last verified
- Nov 2013
- First submitted
- 26 Jan 2012
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Blaha J, Barteczko-Grajek B, Berezowicz P, Charvat J, Chvojka J, Grau T, Holmgren J, Jaschinski U, Kopecky P, Manak J, Moehl M, Paddle J, Pasculli M, Petersson J, Petros S, Radrizzani D, Singh V, Starkopf J. Space GlucoseControl system for blood glucose control in intensive care patients--a European multicentre observational study. BMC Anesthesiol. 2016 Jan 22;16:8. doi: 10.1186/s12871-016-0175-4.
PubMed 26801983
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System
- ClinicalTrials.gov ID
- NCT01523665
- Acronym / sponsor ID
- HC-O-H-1102
- Conditions
- Intensive Care Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Feb 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.
Glucose metabolism is impaired in many critically ill patients and is often aggravated by parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented on most critical care units. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. Several barriers to the implementation of glycemic control have been identified. Most importantly, there is concern about increased frequency of severe hypoglycemic episodes. To overcome these problems Space GlucoseControl was developed as a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges (4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l).
The objective of this non-interventional study is to gain additional information on the performance of the Space GlucoseControl system for glycaemic control in ICU patients when used in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (1 listed)
- Intensive care patients who require blood glucose control by intravenous application of insulin
Key exclusion criteria (1 listed)
- All contraindication of intravenous insulin therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood glucose values: Percentage of time within the chosen glucose target range of 4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l
Time frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
3 secondary outcomes
Frequency of hypoglycaemic episodes
Time frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
Adherence to the advice of the Space GlucoseControl system
Time frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
Blood glucose measurement interval
Time frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
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 27 Nov 2013.
- Derived from this study: PubMed 26801983Blaha J, Barteczko-Grajek B, Berezowicz P, Charvat J, Chvojka J, Grau T, Holmgren J, Jaschinski U, Kopecky P, Manak J, Moehl M, Paddle J, Pasculli M, Petersson J, Petros S, Radrizzani D, Singh V, Starkopf J. Space GlucoseControl system for blood glucose control in intensive care patients--a European multicentre observational study. BMC Anesthesiol. 2016 Jan 22;16:8. doi: 10.1186/s12871-016-0175-4.
Related trials for Intensive Care Patients
Recruiting
Effect of Rutin and Vitamin C on Outcomes in Adults With Sepsis Admitted to the Intensive Care Unit
Sepsis
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
RecruitingObservational study
COMparative Performance of General Purpose Models
Neurosurgical Patients
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Patients, run by B. Braun Melsungen AG at 17 sites in 9 countries.
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 1 inclusion and 1 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 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Czechia, Sweden, Denmark, Germany, Italy and 4 more countries. 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?
Blood glucose values: Percentage of time within the chosen glucose target range of 4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l (time frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.). 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 NCT01523665, 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 27 Nov 2013.