Hyperglycemia in Critically Ill PatientsPhase 4NCT00636714
Comparison of 2 Methods to Achieve Tight Glucose Control in Cardiovascular ICU Patients
A Phase 4 study testing Nursing judgement and Nomogram in people with Hyperglycemia in Critically Ill Patients, run by Unity Health Toronto at 1 site in Canada.
Trial summary
There is current evidence that maintaining ICU patient's blood sugar between 4.4-6.1 saves lives. However, this is difficult to do in the ICU and carries risks of lowering the blood sugar too much. In addition, the best way to achieve this control is not known. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hyperglycemia in Critically Ill Patients
- What is being tested?
- Nursing judgement and Nomogram
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Apr 2010
- Phase
- Phase 4
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- adult CVICU pts
- requires insulin therapy for glucose greater than 8 mmol/L
- anticipated ICU stay > 24 hrs
- not in DKA/HHNK
- mechanically ventilated
Who cannot join
- MD refusal
- no IV access for insulin
- allergy to insulin
- DNR or moribund as determined by the clinical team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Nurse-directed vs Nomogram-directed Intensive Glucose Control in the CVICU
There is current evidence that maintaining ICU patient's blood sugar between 4.4-6.1 saves lives. However, this is difficult to do in the ICU and carries risks of lowering the blood sugar too much. In addition, the best way to achieve this control is not known. Many strict nomograms that provide a standardized approach for nurses have been developed and validated, including one here at SMH. However, these nomograms cannot apply to all patients at all times, especially ICU patients whose needs are rapidly changing. ICU nurses are at the bedside constantly, are very familiar with their patient's needs, and have decades of experience in titrating medication doses without a nomogram to achieve a pre-determined response (i.e. medications to achieve pre-selected blood pressure). Indeed, once the bedside nurse has bought into the importance of the concept of tight glucose control and have been introduced to the nomogram here at SMH, their experience and intuition may be more adaptable to the changing needs of the patient than an inflexible paper nomogram. This study will compare glucose control using our current standard nomogram versus no nomogram (i.e. nurse directed) in order to determine whether the nomogram should continue to be used.
- Conditions
- Hyperglycemia in Critically Ill Patients
- Being tested
- Nursing judgement, Nomogram
- Keywords
- intensive insulin therapy, glucose control, nurse directed, nomogram directed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing judgementBehavioural
Based on the nursing judgement, titrate insulin infusion and determine glucose check frequency to achieve a target glucose of 5-8 mmol/L
NomogramBehavioural
A preprinted order outlining a nomogram with instructions for how insulin infusion should be changed based on measured glucose values and how frequent the glucose checks should be
| Study group | Role | What they receive |
|---|---|---|
| Nurse-directed | Experimental | Using nursing judgement to control blood glucose Receives: Behavioral: Nursing judgement |
| Nomogram-directed | Active comparator | Blood glucose control directed by pre-approved paper nomogram Receives: Behavioral: Nomogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean area-under-the curve for blood glucose within target per shift
Measured: over 12 hours
Secondary outcomes (1)
Hypoglycemia frequency
Measured: per shift
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2010
- Study completionApr 2010
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 Hyperglycemia in Critically Ill PatientsStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clarence Chant, PharmD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636714
- Sponsor's protocol ID
- REB 07-282c
- Status last verified
- Jan 2017
- First submitted
- 7 Mar 2008
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Chant C, Mustard M, Thorpe KE, Friedrich JO. Nurse- vs nomogram-directed glucose control in a cardiovascular intensive care unit. Am J Crit Care. 2012 Jul;21(4):270-8. doi: 10.4037/ajcc2012713.
PubMed 22751370
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Nurse-directed vs Nomogram-directed Intensive Glucose Control in the CVICU
- ClinicalTrials.gov ID
- NCT00636714
- Acronym / sponsor ID
- REB 07-282c
- Conditions
- Hyperglycemia in Critically Ill Patients
- Keywords
- intensive insulin therapy, glucose control, nurse directed, nomogram directed
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 Mar 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.
There is current evidence that maintaining ICU patient's blood sugar between 4.4-6.1 saves lives. However, this is difficult to do in the ICU and carries risks of lowering the blood sugar too much. In addition, the best way to achieve this control is not known. Many strict nomograms that provide a standardized approach for nurses have been developed and validated, including one here at SMH. However, these nomograms cannot apply to all patients at all times, especially ICU patients whose needs are rapidly changing. ICU nurses are at the bedside constantly, are very familiar with their patient's needs, and have decades of experience in titrating medication doses without a nomogram to achieve a pre-determined response (i.e. medications to achieve pre-selected blood pressure). Indeed, once the bedside nurse has bought into the importance of the concept of tight glucose control and have been introduced to the nomogram here at SMH, their experience and intuition may be more adaptable to the changing needs of the patient than an inflexible paper nomogram. This study will compare glucose control using our current standard nomogram versus no nomogram (i.e. nurse directed) in order to determine whether the nomogram should continue to be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-directed | Experimental | Behavioral: Nursing judgementUsing nursing judgement to control blood glucose |
| Nomogram-directed | Active comparator | Behavioral: NomogramBlood glucose control directed by pre-approved paper nomogram |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult CVICU pts
- requires insulin therapy for glucose greater than 8 mmol/L
- anticipated ICU stay > 24 hrs
- not in DKA/HHNK
- mechanically ventilated
Key exclusion criteria (4 listed)
- MD refusal
- no IV access for insulin
- allergy to insulin
- DNR or moribund as determined by the clinical team
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 |
|---|---|---|
| Nursing judgementBased on the nursing judgement, titrate insulin infusion and determine glucose check frequency to achieve a target glucose of 5-8 mmol/L | Behavioural | Nurse-directed |
| NomogramA preprinted order outlining a nomogram with instructions for how insulin infusion should be changed based on measured glucose values and how frequent the glucose checks should be | Behavioural | Nomogram-directed |
Primary outcome
Mean area-under-the curve for blood glucose within target per shift
Time frame: over 12 hours
1 secondary outcome
Hypoglycemia frequency
Time frame: per shift
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 5 Jun 2023.
- Results publication: PubMed 22751370Chant C, Mustard M, Thorpe KE, Friedrich JO. Nurse- vs nomogram-directed glucose control in a cardiovascular intensive care unit. Am J Crit Care. 2012 Jul;21(4):270-8. doi: 10.4037/ajcc2012713.
Related trials for Hyperglycemia in Critically Ill Patients
Not yet recruitingObservational study
Stress Hyperglycemia Ratio and Glucose Variability in Critically Ill Patients
Critical Illness, Hyperglycemia
Not yet recruitingObservational study
Prognostic Value of Stress Hyperglycemia Ratio in Critically Ill Patients
Critical Illness, Hyperglycemia
RecruitingObservational study
Continuous Subcutaneous Glucose Monitoring in Critical Patients
Hyperglycemia, Hypoglycemia
Active, not recruitingPhase 3
Tight Versus Liberal Blood Glucose Control in Adult Critically Ill Patients
Critical Illness, Hyperglycemia
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.
Clarence Chant, PharmD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nursing judgement and Nomogram in people with Hyperglycemia in Critically Ill Patients, run by Unity Health Toronto at 1 site in Canada.
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 6 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 5 Jun 2023. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean area-under-the curve for blood glucose within target per shift (time frame: over 12 hours). 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 NCT00636714, 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 5 Jun 2023.