Critical IllnessNCT00107601
Glucontrol Study: Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients
A study testing Insulin in people with Critical Illness, run by University of Liege at 11 sites in 7 countries.
Trial summary
Glucontrol is a prospective, randomized, controlled, multi-centric study. The present study will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Insulin
- How many people
- 3,500 participants
- Where
- 11 sitesin 7 countries
- Study dates
- Oct 2004to May 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult (older than 18 years old at admission) patients admitted in Intensive Care Unit whatever the reason
Who cannot join
- Absence of the informed consent (as approved by the local ethical committee).
- Life expectancy lower than 24 hours, as estimated upon admission.
- Therapeutic limitation upon admission in ICU
- Pregnancy
Trial locations and contacts
11 sites in 7 countries.
11 sites in 7 countries
Belgium3 sites
C.H.U. Erasme
Brussels
University Hospital Gasthuisberg
Leuven
Centre Hospitalier Universitaire de Liège
Liège, 4000
France3 sites
Hopital Raymond Poincare
Garches
Université Joseph Fournier
Grenoble
Institut Gustave Roussy
Villejuif
About this study
Official title: A Multi-Center Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients
Glucontrol is a prospective, randomized, controlled, multi-centric study. The present study will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively).
This project aims at defining whether a tight glucose control by insulin improves the vital outcome in a mixed population of critically ill patients (around 3000 patients).
Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in the Intensive Care Unit (ICU) and in the hospital, length of ICU stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, and number of red-cell transfusions.
Read the detailed description
Hyperglycemia frequently occurs during critical illness and is commonly implicated in the development of potentially lethal infectious, vascular and metabolic complications. We hypothesize that a control of glycemia by insulin will improve the vital outcome and the rate of complications in a heterogeneous population of critically ill patients. This hypothesis is supported by the findings of a recent trial performed in one surgical intensive care unit, which demonstrated a significant improvement in vital outcome and in several indices of morbidity in patients randomized to a tight control of glycemia. However, these findings can hardly be extrapolated to other conditions, including different types of pathologies and management. The present prospective, randomized, controlled and multicentric study, will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively) and will be powered to detect a 4% decrease in absolute intensive care unit (ICU) mortality. Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in ICU and in the hospital, length of ICU stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, number of red-cell transfusions.
- Conditions
- Critical Illness
- Being tested
- Insulin
- Keywords
- Glucose, Glucose Control, Insulin, Insulin therapy, Critically ill, Intensive Care
- Medical subject headings
- Critical Illness, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality in the Intensive Care Unit (ICU)
Secondary outcomes (10)
Hospital mortality
28 Day mortality
Length of ICU stay
Length of hospital stay
Number of episodes of hypoglycemia and associated clinical signs
Infectious morbidity
Incidence of organ failures
Number of red-cell transfusions
Number of days spent in ICU without life-support: vasopressors/inotropes, cardiac mechanical support, mechanical ventilation, renal replacement therapy
Daily SOFA (Sequential Organ Failure Assessment) Score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2005 (estimated)
- Study startOct 2004
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,500 participants
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Government
- Investigators
- Philippe Devos, Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107601
- Sponsor's protocol ID
- 2004-003914-40
- Other IDs
- EUDRACT Number: 200400391440, 2004
- Status last verified
- Feb 2006
- First submitted
- 5 Apr 2005
- Last updated
- 27 Jun 2008
- Results posted
- No
Publications
Crosara IC, Melot C, Preiser JC. A J-shaped relationship between caloric intake and survival in critically ill patients. Ann Intensive Care. 2015 Dec;5(1):37. doi: 10.1186/s13613-015-0079-3. Epub 2015 Nov 5.
PubMed 26541344Preiser JC, Devos P, Ruiz-Santana S, Melot C, Annane D, Groeneveld J, Iapichino G, Leverve X, Nitenberg G, Singer P, Wernerman J, Joannidis M, Stecher A, Chiolero R. A prospective randomised multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: the Glucontrol study. Intensive Care Med. 2009 Oct;35(10):1738-48. doi: 10.1007/s00134-009-1585-2. Epub 2009 Jul 28.
PubMed 19636533
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT00107601
- Acronym / sponsor ID
- 2004-003914-40
- Conditions
- Critical Illness
- Keywords
- Glucose, Glucose Control, Insulin, Insulin therapy, Critically ill, Intensive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,500 participants
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Belgian Government
- Study start
- Oct 2004
- Study completion
- May 2006
- First posted
- 6 Apr 2005 (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.
Glucontrol is a prospective, randomized, controlled, multi-centric study. The present study will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively).
This project aims at defining whether a tight glucose control by insulin improves the vital outcome in a mixed population of critically ill patients (around 3000 patients).
Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in the Intensive Care Unit (ICU) and in the hospital, length of ICU stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, and number of red-cell transfusions.
Detailed description
Hyperglycemia frequently occurs during critical illness and is commonly implicated in the development of potentially lethal infectious, vascular and metabolic complications. We hypothesize that a control of glycemia by insulin will improve the vital outcome and the rate of complications in a heterogeneous population of critically ill patients. This hypothesis is supported by the findings of a recent trial performed in one surgical intensive care unit, which demonstrated a significant improvement in vital outcome and in several indices of morbidity in patients randomized to a tight control of glycemia. However, these findings can hardly be extrapolated to other conditions, including different types of pathologies and management. The present prospective, randomized, controlled and multicentric study, will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively) and will be powered to detect a 4% decrease in absolute intensive care unit (ICU) mortality. Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in ICU and in the hospital, length of ICU stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, number of red-cell transfusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult (older than 18 years old at admission) patients admitted in Intensive Care Unit whatever the reason
Key exclusion criteria (4 listed)
- Absence of the informed consent (as approved by the local ethical committee).
- Life expectancy lower than 24 hours, as estimated upon admission.
- Therapeutic limitation upon admission in ICU
- Pregnancy
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 |
|---|---|---|
| Insulin | Drug | – |
Primary outcome
Mortality in the Intensive Care Unit (ICU)
10 secondary outcomes
Hospital mortality
28 Day mortality
Length of ICU stay
Length of hospital stay
Number of episodes of hypoglycemia and associated clinical signs
Infectious morbidity
Incidence of organ failures
Number of red-cell transfusions
Number of days spent in ICU without life-support: vasopressors/inotropes, cardiac mechanical support, mechanical ventilation, renal replacement therapy
Daily SOFA (Sequential Organ Failure Assessment) Score
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 Jun 2008.
- Derived from this study: PubMed 26541344Crosara IC, Melot C, Preiser JC. A J-shaped relationship between caloric intake and survival in critically ill patients. Ann Intensive Care. 2015 Dec;5(1):37. doi: 10.1186/s13613-015-0079-3. Epub 2015 Nov 5.
- Derived from this study: PubMed 19636533Preiser JC, Devos P, Ruiz-Santana S, Melot C, Annane D, Groeneveld J, Iapichino G, Leverve X, Nitenberg G, Singer P, Wernerman J, Joannidis M, Stecher A, Chiolero R. A prospective randomised multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: the Glucontrol study. Intensive Care Med. 2009 Oct;35(10):1738-48. doi: 10.1007/s00134-009-1585-2. Epub 2009 Jul 28.
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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.
Philippe Devos principal investigator
University of Liege
11 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin in people with Critical Illness, run by University of Liege at 11 sites in 7 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 4 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 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belgium, France, Germany, Israel, Netherlands and 2 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?
Mortality in the Intensive Care Unit (ICU). 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 NCT00107601, which also lists 2 linked publications.
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 Jun 2008.