HyperglycemiaPhase 3INSUREANCT00591071
Impact of 2 Blood Glucose Levels on Hospital Mortality in Patients Admitted in ICU
A Phase 3 study of Hyperglycemia and Critically Ill Patients, run by Poissy-Saint Germain Hospital at 2 sites in France.
Trial summary
During hospitalization in the intensive care unit (ICU), the occurrence of a blood glucose imbalance is frequent and associated with increased mortality. These observations have resulted in the hypothesis that intensive insulin therapy designed to control blood glucose would improve the prognosis of patients admitted… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Critically Ill Patients
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2008to Sep 2010
- Phase
- Phase 3
- 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
- over 18 years of age
- requiring mechanical ventilation with an expected duration above 48 hours
- patient or next of kind refusal of study participation
- pregnant women
Who cannot join
- admission for cardiac arrest
- admission for an attempt of drug autolysis or acute drunkenness
- admission for hyperosmolar and/or ketoacidosis coma
- admission for massive cerebral hemorrhage
- admission from an another ICU
- admission after surgery without any other organ failure than respiratory support (with FiO2 below 50% and PeeP below 5cm H2O)
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
Medico-surgical ICU Louise Michel Hospital
Évry, 91014 Cedex
Andry Van de Louw, MD, andry.vandelouw@ch-sud-francilien.fr
Andry Van de Louw, MD
- Recruiting
Medico-surgical ICU Poissy Saint Germain Hospital
Poissy, 78300
Jean-Claude Lacherade, MD, 33 1 39 27 54 55, jclacherade@chi-poissy-st-germain.fr
Jean-Claude Lacherade, MD
About this study
Official title: Multicentre Randomized Trial Assessing the Impact of Maintaining 2 Blood Glucose Levels on Hospital Mortality in Patients Admitted to the ICU (INSUREA STUDY)
During hospitalization in the intensive care unit (ICU), the occurrence of a blood glucose imbalance is frequent and associated with increased mortality. These observations have resulted in the hypothesis that intensive insulin therapy designed to control blood glucose would improve the prognosis of patients admitted into the ICU. In a prospective, randomized, single center study in a surgical ICU during which the majority of patients had undergone cardiac surgery, intensive insulin therapy with the objective to maintain glycemia below 110 mg/dl (6.1 mmol/L) provided a significant reduction in ICU mortality and hospital mortality compared to a group with a glycemic objective of 200 mg/dl.
In a recent published article, the beneficial effect of intensive insulin therapy seems less obvious in a randomized single center study in a medical ICU. One of the potential factors limiting the impact of a therapeutic strategy like this one is the absence of achieving strict glycemic control for all patients on intensive insulin therapy. Additionally, the implementation of such a therapeutic strategy results in an increased risk of hypoglycemia, the consequences of which on morbidity remain unclear.
The aim of our study is to determine, in a mixed population of medical and surgical patients admitted to the ICU, requiring artificial ventilation with a expected duration above 48 hours, the impact of effective strict glycemic control (<6,1 mmol/l) compared to a conventional glycemic control (<11mmol/l) on hospital mortality.
Read the detailed description
In both randomization arms, continuous insulin infusion will be used via the venous route of administration. Rapid action insulin Novorapid HM (Novo Nordisk, Copenhagen, Denmark) will be used.
ICU patient management requires many intravenously administered treatments in a limited number of venous lines (catecholamines, sedation, feeding, vascular filling, antiotics…). This situation does not enable to dedicate an infusion line for the intravenous administration of insulin. Despite continuous administration of insulin infusion, the concomitant administration of other treatments in the same infusion line obviously leads to significant variations in the flow of insulin actually delivered, which can lead to variations in blood glucose and adjustments secondary to the inappropriate dose of insulin. To limit this phenomenon, an OCTOPUS (Vygon, Ecouen, France) type infusion connector will be added. The infusion connector is made of 2 infusion lines one of which will be exclusively dedicated to insulin therapy subsequently limiting the risk of variations in insulin administration flow.
The determination of the number of subjects to include was carried out by using a 45% hospital mortality hypothesis in the conventional glycemic control group. and a 32 % hospital mortality hypothesis in the strict glycemic control group.
- Conditions
- Hyperglycemia, Critically Ill Patients
- Being tested
- Strict glycemic control, Conventional glycemic control
- Keywords
- hyperglycemia, insulin treatment, intensive care, hypoglycemia, mechanical ventilation, critically ill patients
- Medical subject headings
- Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strict glycemic controlOther
Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level below 6.1 mmol/L
Conventional glycemic controlOther
Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level at 11 mmol/L
| Study group | Role | What they receive |
|---|---|---|
| B | Active comparator | Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level at 11 mmol/L Receives: Other: Conventional glycemic control |
| A | Experimental | Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level below 6.1 mmol/L Receives: Other: Strict glycemic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
Measured: Length of hospital stay
Secondary outcomes (4)
incidence of severe hypoglycemia (below 2.2 mmol/l)
Measured: lenght of insulin administration in ICU
ICU mortality
Measured: Length of ICU stay
Quality of obtained glycemic control in the 2 arms of the study
Measured: Length of Continuous Insulin treatment
Incidence of neuromyopathy in the ICU
Measured: Length of ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poissy-Saint Germain Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Claude Lacherade, MD, Principal investigator, Medico-surgical ICU Poissy Saint Germain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591071
- Sponsor's protocol ID
- 432
- Acronym
- INSUREA
- Status last verified
- Dec 2007
- First submitted
- 20 Dec 2007
- Last updated
- 14 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomized Trial Assessing the Impact of Maintaining 2 Blood Glucose Levels on Hospital Mortality in Patients Admitted to the ICU (INSUREA STUDY)
- ClinicalTrials.gov ID
- NCT00591071
- Acronym / sponsor ID
- INSUREA / 432
- Conditions
- Hyperglycemia, Critically Ill Patients
- Keywords
- hyperglycemia, insulin treatment, intensive care, hypoglycemia, mechanical ventilation, critically ill patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Poissy-Saint Germain HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 11 Jan 2008 (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.
During hospitalization in the intensive care unit (ICU), the occurrence of a blood glucose imbalance is frequent and associated with increased mortality. These observations have resulted in the hypothesis that intensive insulin therapy designed to control blood glucose would improve the prognosis of patients admitted into the ICU. In a prospective, randomized, single center study in a surgical ICU during which the majority of patients had undergone cardiac surgery, intensive insulin therapy with the objective to maintain glycemia below 110 mg/dl (6.1 mmol/L) provided a significant reduction in ICU mortality and hospital mortality compared to a group with a glycemic objective of 200 mg/dl.
In a recent published article, the beneficial effect of intensive insulin therapy seems less obvious in a randomized single center study in a medical ICU. One of the potential factors limiting the impact of a therapeutic strategy like this one is the absence of achieving strict glycemic control for all patients on intensive insulin therapy. Additionally, the implementation of such a therapeutic strategy results in an increased risk of hypoglycemia, the consequences of which on morbidity remain unclear.
The aim of our study is to determine, in a mixed population of medical and surgical patients admitted to the ICU, requiring artificial ventilation with a expected duration above 48 hours, the impact of effective strict glycemic control (<6,1 mmol/l) compared to a conventional glycemic control (<11mmol/l) on hospital mortality.
Detailed description
In both randomization arms, continuous insulin infusion will be used via the venous route of administration. Rapid action insulin Novorapid HM (Novo Nordisk, Copenhagen, Denmark) will be used.
ICU patient management requires many intravenously administered treatments in a limited number of venous lines (catecholamines, sedation, feeding, vascular filling, antiotics…). This situation does not enable to dedicate an infusion line for the intravenous administration of insulin. Despite continuous administration of insulin infusion, the concomitant administration of other treatments in the same infusion line obviously leads to significant variations in the flow of insulin actually delivered, which can lead to variations in blood glucose and adjustments secondary to the inappropriate dose of insulin. To limit this phenomenon, an OCTOPUS (Vygon, Ecouen, France) type infusion connector will be added. The infusion connector is made of 2 infusion lines one of which will be exclusively dedicated to insulin therapy subsequently limiting the risk of variations in insulin administration flow.
The determination of the number of subjects to include was carried out by using a 45% hospital mortality hypothesis in the conventional glycemic control group. and a 32 % hospital mortality hypothesis in the strict glycemic control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Active comparator | Other: Conventional glycemic controlContinuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level at 11 mmol/L |
| A | Experimental | Other: Strict glycemic controlContinuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level below 6.1 mmol/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 18 years of age
- requiring mechanical ventilation with an expected duration above 48 hours
- patient or next of kind refusal of study participation
- pregnant women
Key exclusion criteria (6 listed)
- admission for cardiac arrest
- admission for an attempt of drug autolysis or acute drunkenness
- admission for hyperosmolar and/or ketoacidosis coma
- admission for massive cerebral hemorrhage
- admission from an another ICU
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 |
|---|---|---|
| Strict glycemic controlContinuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level below 6.1 mmol/L | Other | A |
| Conventional glycemic controlContinuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level at 11 mmol/L | Other | B |
Primary outcome
Hospital mortality
Time frame: Length of hospital stay
4 secondary outcomes
incidence of severe hypoglycemia (below 2.2 mmol/l)
Time frame: lenght of insulin administration in ICU
ICU mortality
Time frame: Length of ICU stay
Quality of obtained glycemic control in the 2 arms of the study
Time frame: Length of Continuous Insulin treatment
Incidence of neuromyopathy in the ICU
Time frame: Length of ICU stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2008.
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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.
Jean-Claude Lacherade, MD principal investigator
Medico-surgical ICU Poissy Saint Germain Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Hyperglycemia and Critically Ill Patients, run by Poissy-Saint Germain Hospital at 2 sites in France.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Claude Lacherade, MD (33 1 39 27 52 02, jclacherade@chi-poissy-st-germain.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital mortality (time frame: Length of hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2008.