Stress HyperglycemiaNCT02847104
Medical ICU Paper-based Dynamic Insulin Protocol
An observational study of Stress Hyperglycemia, run by University Hospital, Caen.
Trial summary
Intensive care unit (ICU) patients commonly display hyperglycemia, even without previously known diabetes. It was demonstrated that hyperglycemia was associated with increased hospital mortality in various medical and surgical ICU situations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Hyperglycemia
- What is being tested?
- dynamic insulin protocol and static insulin protocol
- Type of treatment
- Injection or infusion
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Jun 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective trial involved adult patients who were admitted to the medical intensive care department of a French university hospital to compare the effects of two continuous intravenous insulin infusion (CIII) protocols on glycemic variability. According to the local protocol, patients with two consecutive capillary blood glucose measurements greater than 180 mg/dL (9.9 mmol/L), one hour apart, were considered to require CIII and were included in the trial. All of the patients or their family members received written information about the trial.
Who may be able to join
- Male or female adult patient admitted to intensive care unit
- Intensive care unit stay > 48 hours
- Stress hyperglycemia above 9.9 mmil/L indicating the need of continuous intravenous insulin infusion
Who cannot join
- Previous diabetes
- Acute metabolic event (ketoacidosis or hyperosmolarity)
- Insulin/dextrose infusion for hyperkalemia treatment
About this study
Official title: Impact of a Paper-based Dynamic Insulin Infusion Protocol on Glycemic Variability, Time in Target and Hypoglycemic Risk: a Stepped Wedge Trial in Medical ICU Patients
Intensive care unit (ICU) patients commonly display hyperglycemia, even without previously known diabetes. It was demonstrated that hyperglycemia was associated with increased hospital mortality in various medical and surgical ICU situations. However, discrepant results from recent randomized, clinical trials of tight blood glucose control in ICUs have not allowed conclusions regarding whether there is a causal link between hyperglycemia and ICU mortality. In addition to the mean blood glucose level, glucose variability has recently been emphasized as an independent predictor of ICU and hospital mortality. This concept has been described in a wide variety of medical, surgical and trauma ICU patients. In all of these settings, glycemic variability was measured with various indices but was steadily associated with ICU and/or hospital mortality in non-diabetic ICU patients. Conversely, glycemic variability was either weakly or not associated with mortality in ICU patients with previously known diabetes. Notably, all of these data have been observational, and interventional trials remain lacking to assess the impact of glycemic variability reduction on ICU mortality and thus to demonstrate causality. However, glycemic variability was considered sufficiently important to be mentioned in recent international guidelines for the management of hyperglycemia in critically ill patients. In these publications, experts from the American College of Critical Care Medicine emphasized that glycemia should be maintained at less than 9.9 mmol/L in ICU patients while avoiding hypoglycemia and minimizing glycemic variability. To achieve these goals, computer-based insulin infusion protocols have demonstrated their superiority to paper-based protocols. Glucose concentrations, variation per unit of time between the last and current glucose measurements, insulin dosage, and carbohydrate intake were the main input variables used in these different computerized algorithms. However, such protocols are not widely available because commercial systems have licensing fees and academic protocols do not always go beyond the pilot phase.
To address this issue, the investigators adapted a previously validated, paper-based, dynamic protocol (DP) to an actual recommended glycemic target range. Our aim was to assess the efficacy, safety, feasibility and acceptance by nurses of this dynamic insulin protocol, compared to a paper-based, sliding scale static protocol (SP).
- Conditions
- Stress Hyperglycemia
- Being tested
- dynamic insulin protocol, static insulin protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic insulin protocolOther
Adaptation of insulin infusion rate according to hourly capillary blood glucose and dynamic insulin protocol
static insulin protocolOther
Adaptation of insulin infusion rate according to hourly capillary blood glucose and static insulin protocol
| Study group | Role | What they receive |
|---|---|---|
| dynamic insulin protocol | patients received intravenous insulin infusion according to a dynamic insulin protocol Receives: Other: dynamic insulin protocol | |
| static insulin protocol | patients received intravenous insulin infusion according to a static insulin protocol Receives: Other: static insulin protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAGE (mean amplitude of glycemic excursion) index
Measured: calculated during the 5 first days after beginning of insulin infusion
Secondary outcomes (13)
MAG: mean absolute glucose change
Measured: calculated during the 5 first days after beginning of insulin infusion
LI: lability index
Measured: calculated during the 5 first days after beginning of insulin infusion
SD: standard deviation of glycemia
Measured: calculated during the 5 first days after beginning of insulin infusion
CV: coefficient of variation of glycemia
Measured: calculated during the 5 first days after beginning of insulin infusion
LBGI: low blood glucose index
Measured: calculated during the 5 first days after beginning of insulin infusion
HBGI: high blood glucose index
Measured: calculated during the 5 first days after beginning of insulin infusion
GRADE: glycemic risk assessment diabetes equation
Measured: calculated during the 5 first days after beginning of insulin infusion
M-Value
Measured: calculated during the 5 first days after beginning of insulin infusion
mean blood glucose
Measured: calculated during the 5 first days after beginning of insulin infusion
time spent in the target range (140 to 180 mg/dL - 7.7 to 9.9 mmol/L)
Measured: calculated during the 5 first days after beginning of insulin infusion
low blood glucose episodes (less than 80 and 60 mg/dL - 4.4 and 3.3 mmol/L) (n/patient)
Measured: measured during the 5 first days after beginning of insulin infusion
severe hypoglycemia (less than 40 mg/dL - 2.2 mmol/L) (n/patient)
Measured: measured during the 5 first days after beginning of insulin infusion
time before the first glucose value in the target range (h)
Measured: calculated during the 5 first days after beginning of insulin infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- damien du cheyron, PhD, Study chair, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847104
- Sponsor's protocol ID
- VARIREA
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Paper-based Dynamic Insulin Infusion Protocol on Glycemic Variability, Time in Target and Hypoglycemic Risk: a Stepped Wedge Trial in Medical ICU Patients
- ClinicalTrials.gov ID
- NCT02847104
- Acronym / sponsor ID
- VARIREA
- Conditions
- Stress Hyperglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Jul 2016 (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.
Intensive care unit (ICU) patients commonly display hyperglycemia, even without previously known diabetes. It was demonstrated that hyperglycemia was associated with increased hospital mortality in various medical and surgical ICU situations. However, discrepant results from recent randomized, clinical trials of tight blood glucose control in ICUs have not allowed conclusions regarding whether there is a causal link between hyperglycemia and ICU mortality. In addition to the mean blood glucose level, glucose variability has recently been emphasized as an independent predictor of ICU and hospital mortality. This concept has been described in a wide variety of medical, surgical and trauma ICU patients. In all of these settings, glycemic variability was measured with various indices but was steadily associated with ICU and/or hospital mortality in non-diabetic ICU patients. Conversely, glycemic variability was either weakly or not associated with mortality in ICU patients with previously known diabetes. Notably, all of these data have been observational, and interventional trials remain lacking to assess the impact of glycemic variability reduction on ICU mortality and thus to demonstrate causality. However, glycemic variability was considered sufficiently important to be mentioned in recent international guidelines for the management of hyperglycemia in critically ill patients. In these publications, experts from the American College of Critical Care Medicine emphasized that glycemia should be maintained at less than 9.9 mmol/L in ICU patients while avoiding hypoglycemia and minimizing glycemic variability. To achieve these goals, computer-based insulin infusion protocols have demonstrated their superiority to paper-based protocols. Glucose concentrations, variation per unit of time between the last and current glucose measurements, insulin dosage, and carbohydrate intake were the main input variables used in these different computerized algorithms. However, such protocols are not widely available because commercial systems have licensing fees and academic protocols do not always go beyond the pilot phase.
To address this issue, the investigators adapted a previously validated, paper-based, dynamic protocol (DP) to an actual recommended glycemic target range. Our aim was to assess the efficacy, safety, feasibility and acceptance by nurses of this dynamic insulin protocol, compared to a paper-based, sliding scale static protocol (SP).
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dynamic insulin protocol | – | Other: dynamic insulin protocolpatients received intravenous insulin infusion according to a dynamic insulin protocol |
| static insulin protocol | – | Other: static insulin protocolpatients received intravenous insulin infusion according to a static insulin protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective trial involved adult patients who were admitted to the medical intensive care department of a French university hospital to compare the effects of two continuous intravenous insulin infusion (CIII) protocols on glycemic variability. According to the local protocol, patients with two consecutive capillary blood glucose measurements greater than 180 mg/dL (9.9 mmol/L), one hour apart, were considered to require CIII and were included in the trial. All of the patients or their family members received written information about the trial.
Key inclusion criteria (3 listed)
- Male or female adult patient admitted to intensive care unit
- Intensive care unit stay > 48 hours
- Stress hyperglycemia above 9.9 mmil/L indicating the need of continuous intravenous insulin infusion
Key exclusion criteria (3 listed)
- Previous diabetes
- Acute metabolic event (ketoacidosis or hyperosmolarity)
- Insulin/dextrose infusion for hyperkalemia treatment
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 |
|---|---|---|
| dynamic insulin protocolAdaptation of insulin infusion rate according to hourly capillary blood glucose and dynamic insulin protocol | Other | dynamic insulin protocol |
| static insulin protocolAdaptation of insulin infusion rate according to hourly capillary blood glucose and static insulin protocol | Other | static insulin protocol |
Primary outcome
MAGE (mean amplitude of glycemic excursion) index
Time frame: calculated during the 5 first days after beginning of insulin infusion
13 secondary outcomes
MAG: mean absolute glucose change
Time frame: calculated during the 5 first days after beginning of insulin infusion
LI: lability index
Time frame: calculated during the 5 first days after beginning of insulin infusion
SD: standard deviation of glycemia
Time frame: calculated during the 5 first days after beginning of insulin infusion
CV: coefficient of variation of glycemia
Time frame: calculated during the 5 first days after beginning of insulin infusion
LBGI: low blood glucose index
Time frame: calculated during the 5 first days after beginning of insulin infusion
HBGI: high blood glucose index
Time frame: calculated during the 5 first days after beginning of insulin infusion
GRADE: glycemic risk assessment diabetes equation
Time frame: calculated during the 5 first days after beginning of insulin infusion
M-Value
Time frame: calculated during the 5 first days after beginning of insulin infusion
mean blood glucose
Time frame: calculated during the 5 first days after beginning of insulin infusion
time spent in the target range (140 to 180 mg/dL - 7.7 to 9.9 mmol/L)
Time frame: calculated during the 5 first days after beginning of insulin infusion
low blood glucose episodes (less than 80 and 60 mg/dL - 4.4 and 3.3 mmol/L) (n/patient)
Time frame: measured during the 5 first days after beginning of insulin infusion
severe hypoglycemia (less than 40 mg/dL - 2.2 mmol/L) (n/patient)
Time frame: measured during the 5 first days after beginning of insulin infusion
time before the first glucose value in the target range (h)
Time frame: calculated during the 5 first days after beginning of insulin infusion
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 28 Jul 2016.
- Individual participant dataSharing planned: Undecided
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Not yet recruitingObservational study
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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.
damien du cheyron, PhD study chair
University Hospital, Caen
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Hyperglycemia, run by University Hospital, Caen.
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 3 inclusion and 3 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 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
MAGE (mean amplitude of glycemic excursion) index (time frame: calculated during the 5 first days after beginning of insulin infusion). 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 28 Jul 2016.