Intensive CareNCT00410852
Efficacy and Safety of Three Insulin Protocols in Medical Intensive Care Unit Patients
A study testing Computer-assisted IV insulin infusion protocol (algorithm A) and Conventional Intermittent Insulin Protocol (Algorithm C) in people with Intensive Care, run by Hospital Israelita Albert Einstein at 5 sites in Brazil.
Trial summary
To evaluate the efficacy and safety of three insulin algorithms in medical ICU patients (MICU). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Intensive Care
- What is being tested?
- Computer-assisted IV insulin infusion protocol (algorithm A) and Conventional Intermittent Insulin Protocol (Algorithm C)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 5 sitesBrazil
- Study dates
- May 2005to Mar 2007
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Criteria 1, 2 and 3 must be present:
- Clinical patients admitted to an Intensive Care Unit
- At least one blood glucose measurement >= 150 mg/dL (capilar, venous or arterial blood)
- At least one of the following:
- Patient on mechanical ventilation for an acute process, with expected duration of mechanical ventilation of at least 24 hours
- Polytrauma patients
- Severe burn patients
- Systemic Inflammatory Response Syndrome (modified criteria), with at least three of the following: core temperature >=38°C or <=36°C; heart rate >=90 beats/min, except in patients with a medical condition or receiving a medication known to prevent tachycardia; respiratory heart rate >= 20 breaths/min or a PaCO2 <=32mmHg, or the use of mechanical ventilation for an acute process; white-cell count of >=12.000/mm3 or <=4.000/mm3 or a differential count showing >10% percent immature neutrophils
Who cannot join
- Age < 21 years
- Surgical patients (surgery less than 24hs before admission to ICU)
- Diabetic ketoacidosis
- Non-ketotic hyperosmolar state
- Patients with defined diagnosis of brain death
- Moribund state in which death is perceived to be imminent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Complexo Hospitalar UNIMED
Joinville, Santa Catarina
Hospital Dona Helena
Joinville, Santa Catarina
Hospital Regional Sao Jose
Joinville, Santa Catarina
Hospital Estadual Mario Covas
Santo André, São Paulo
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05651-901
About this study
Official title: Randomized Study to Evaluate the Efficacy and Safety of Two Endovenous Insulin Protocols and a Subcutaneous Insulin Protocol in Critically Ill Patients
To evaluate the efficacy and safety of three insulin algorithms in medical ICU patients (MICU).
Read the detailed description
Strict glycemic control has been recommended for critically ill patients. However, its implementation may face difficulties with increased nursing workload, inadequate glucose control and higher risk of hypoglycemia.
We designed a computer guided protocol to adjust endovenous insulin infusion aiming glucose levels between 100mg/dl and 130 mg/dl. This trial evaluates the efficacy and safety of this protocol (algorithm A), compared to a standard endovenous insulin infusion protocol (algorithm B) and a conventional subcutaneous insulin protocol (algorithm C).
Methods : MICU patients with at least one blood glucose ≥ 150 mg/dL and who are on mechanical ventilation, or had SIRS, or are admitted because of trauma or burn will be randomized to one of the following treatments: algorithm A - continuous insulin infusion with adjustments guided by hand held device or desktop software targeting glucose levels between 100mg/dL-130mg/dL; algorithm B - continuous insulin aiming glucose levels between 80mg/dl-110mg/dl using Van den Berghe's insulin protocol; algorithm C - conventional treatment - intermittent subcutaneous administration of insulin if blood glucose levels exceeds 150mg/dL; insulin will be administered as IV boluses in hypotensive patients.
The randomization list was generated in blocks of six by computer software. Patients will be randomly assigned in a 1:1:1 ratio to have their glucose controlled by one of the three insulin algorithms with the use of a central, computerized system accessed by Internet, permitting concealment of allocation list. Randomization will be stratified according to study site.
The study is planned to enroll 165 patients in order to have 80% power to detect a 20mg/dl difference in blood glucose means between groups, assuming standard deviation equal to 33 mg/dl and two-tailed alpha equal to 0.05. Efficacy will be measured by the mean of patients' median blood glucose and safety measured by the incidence of hypoglycemia (≤40 mg/dL). Analysis will follow the intention-to-treat principle.
- Conditions
- Intensive Care
- Being tested
- Computer-assisted IV insulin infusion protocol (algorithm A), Leuven Strict glycemic control protocol (Algorithm B), Conventional Intermittent Insulin Protocol (Algorithm C)
- Keywords
- Insulin, Hyperglycemia, Hypoglycemia, Intensive care, Critical care
- Medical subject headings
- Insulin Resistance, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted IV insulin infusion protocol (algorithm A)Procedure or surgery
Computer assisted insulin protocol (CAIP), with continuous intravenous insulin adjustments aiming blood glucose levels between 100 mg/dl and 130 mg/dl.
Leuven Strict glycemic control protocol (Algorithm B)Procedure or surgery
Leuven protocol: continuous intravenous insulin infusion aimiming blood glucose levels between 80mg/dl and 110mg/dl.
Conventional Intermittent Insulin Protocol (Algorithm C)Procedure or surgery
Conventional treatment: intermitent subcutaneous insulin according to a sliding scale, starting with blood glucose levels higher than 150mg/dl.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Procedure: Computer-assisted IV insulin infusion protocol (algorithm A) |
| B | Experimental | Not described Receives: Procedure: Leuven Strict glycemic control protocol (Algorithm B) |
| C | Active comparator | Not described Receives: Procedure: Conventional Intermittent Insulin Protocol (Algorithm C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: mean of patients' median blood glucose during ICU stay
Measured: ICU Stay
Safety: incidence of hypoglycemia (≤40 mg/dL)during ICU stay
Measured: ICU stay
Secondary outcomes (11)
Death from any cause
Measured: ICU and in-hospital
ICU and hospital length of stay
Measured: ICU and in-hospital
Five-day variation in SOFA score
Measured: Five days
90-day health status
Measured: 90 days
Days on mechanical ventilation
Initiation of dialysis
Days on antibiotics
Days on inotropic of vasopressor support
Necessity of red blood cell transfusions
Bilirubin peak
Platelets through
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startMay 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive CareStudies 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
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Alexandre B Cavalcanti, MD, Study chair, Hospital Israelita Albert EinsteinEliezer Silva, PhD, Study director, Hospital Israelita Albert EinsteinJose Eluf-Neto, PhD, Study director, Departamento de Medicina Preventiva, Faculdade de Medicina da Universidade de Sao PauloMilton Caldeira, MD, Principal investigator, Hospital Regional Sao JoseGlauco Westphal, MD, Principal investigator, Centro Hospitalar UNIMED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410852
- Sponsor's protocol ID
- FAPESP 2005/50557-5
- Status last verified
- Oct 2007
- First submitted
- 12 Dec 2006
- Last updated
- 2 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study to Evaluate the Efficacy and Safety of Two Endovenous Insulin Protocols and a Subcutaneous Insulin Protocol in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00410852
- Acronym / sponsor ID
- FAPESP 2005/50557-5
- Conditions
- Intensive Care
- Keywords
- Insulin, Hyperglycemia, Hypoglycemia, Intensive care, Critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 13 Dec 2006 (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.
To evaluate the efficacy and safety of three insulin algorithms in medical ICU patients (MICU).
Detailed description
Strict glycemic control has been recommended for critically ill patients. However, its implementation may face difficulties with increased nursing workload, inadequate glucose control and higher risk of hypoglycemia.
We designed a computer guided protocol to adjust endovenous insulin infusion aiming glucose levels between 100mg/dl and 130 mg/dl. This trial evaluates the efficacy and safety of this protocol (algorithm A), compared to a standard endovenous insulin infusion protocol (algorithm B) and a conventional subcutaneous insulin protocol (algorithm C).
Methods : MICU patients with at least one blood glucose ≥ 150 mg/dL and who are on mechanical ventilation, or had SIRS, or are admitted because of trauma or burn will be randomized to one of the following treatments: algorithm A - continuous insulin infusion with adjustments guided by hand held device or desktop software targeting glucose levels between 100mg/dL-130mg/dL; algorithm B - continuous insulin aiming glucose levels between 80mg/dl-110mg/dl using Van den Berghe's insulin protocol; algorithm C - conventional treatment - intermittent subcutaneous administration of insulin if blood glucose levels exceeds 150mg/dL; insulin will be administered as IV boluses in hypotensive patients.
The randomization list was generated in blocks of six by computer software. Patients will be randomly assigned in a 1:1:1 ratio to have their glucose controlled by one of the three insulin algorithms with the use of a central, computerized system accessed by Internet, permitting concealment of allocation list. Randomization will be stratified according to study site.
The study is planned to enroll 165 patients in order to have 80% power to detect a 20mg/dl difference in blood glucose means between groups, assuming standard deviation equal to 33 mg/dl and two-tailed alpha equal to 0.05. Efficacy will be measured by the mean of patients' median blood glucose and safety measured by the incidence of hypoglycemia (≤40 mg/dL). Analysis will follow the intention-to-treat principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Computer-assisted IV insulin infusion protocol (algorithm A) |
| B | Experimental | Procedure: Leuven Strict glycemic control protocol (Algorithm B) |
| C | Active comparator | Procedure: Conventional Intermittent Insulin Protocol (Algorithm C) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Criteria 1, 2 and 3 must be present:
Key exclusion criteria (6 listed)
- Age < 21 years
- Surgical patients (surgery less than 24hs before admission to ICU)
- Diabetic ketoacidosis
- Non-ketotic hyperosmolar state
- Patients with defined diagnosis of brain death
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 |
|---|---|---|
| Computer-assisted IV insulin infusion protocol (algorithm A)Computer assisted insulin protocol (CAIP), with continuous intravenous insulin adjustments aiming blood glucose levels between 100 mg/dl and 130 mg/dl. | Procedure or surgery | A |
| Leuven Strict glycemic control protocol (Algorithm B)Leuven protocol: continuous intravenous insulin infusion aimiming blood glucose levels between 80mg/dl and 110mg/dl. | Procedure or surgery | B |
| Conventional Intermittent Insulin Protocol (Algorithm C)Conventional treatment: intermitent subcutaneous insulin according to a sliding scale, starting with blood glucose levels higher than 150mg/dl. | Procedure or surgery | C |
Primary outcome
Efficacy: mean of patients' median blood glucose during ICU stay
Time frame: ICU Stay
Safety: incidence of hypoglycemia (≤40 mg/dL)during ICU stay
Time frame: ICU stay
11 secondary outcomes
Death from any cause
Time frame: ICU and in-hospital
ICU and hospital length of stay
Time frame: ICU and in-hospital
Five-day variation in SOFA score
Time frame: Five days
90-day health status
Time frame: 90 days
Days on mechanical ventilation
Initiation of dialysis
Days on antibiotics
Days on inotropic of vasopressor support
Necessity of red blood cell transfusions
Bilirubin peak
Platelets through
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 2 Nov 2007.
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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.
Alexandre B Cavalcanti, MD study chair
Hospital Israelita Albert Einstein
Eliezer Silva, PhD study director
Hospital Israelita Albert Einstein
Jose Eluf-Neto, PhD study director
Departamento de Medicina Preventiva, Faculdade de Medicina da Universidade de Sao Paulo
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-assisted IV insulin infusion protocol (algorithm A) and Conventional Intermittent Insulin Protocol (Algorithm C) in people with Intensive Care, run by Hospital Israelita Albert Einstein at 5 sites in Brazil.
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 8 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: finished, as of the sponsor's last update on 2 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. 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?
Efficacy: mean of patients' median blood glucose during ICU stay (time frame: ICU Stay). The study lists 2 primary outcomes in all. 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 2 Nov 2007.