SepsisNCT02980588
The Effects of SGC on Glucose Control in Critically Ill Patients With Sepsis
A study of Sepsis and Hyperglycemia, run by Southeast University, China.
Trial summary
Poorly glycemic control in critically ill patients can increase their mortality, while safe and efficient glucose control is laborious and time-consuming. The Space Glucose Control which is installed with eMPC(enhanced Model Predictive Control) can get the blood glucose target range safely and effectively through… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Hyperglycemia, Critical Illness
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Sep 2017
- 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
- Admitted to the ICU
- At least one BG measurement 9.0mmol/L or higher
- Expected to stay in ICU ≥3 days;
- critically ill patients with sepsis
- SOFA score≤2
Who cannot join
- Aged < 18 years;
- Admitted because of diabetic ketoacidosis or nonketotic hyperosmolar state
- Pregnant
- In a state in which death was perceived as imminent
- Without written informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparing SGC and Conventional Empiric Treatment for Glucose Control in Critically Ill Patients With Sepsis in ICU
Poorly glycemic control in critically ill patients can increase their mortality, while safe and efficient glucose control is laborious and time-consuming. The Space Glucose Control which is installed with eMPC(enhanced Model Predictive Control) can get the blood glucose target range safely and effectively through regulating insulin dose rate, and decrease the glucose variability. This study is a random controlled trial involving the patients with sepsis in intensive care unit in order to evaluate the difference of safety and efficacy of blood glucose control between SGC directed and conventional treatment. At last, the trial results can determine whether the Space Glucose Control can control blood glucose safely and effectively in the patients with sepsis in intensive care units.
Read the detailed description
Design: The study was conducted as a single-centre, open randomized controlled, parallel trial.
Study population: Adult general ICU patients with sepsis and assumed to require at least 3 days of intensive care were recruited. Patients fulfilling the inclusion criterion of glucose≥9.0 mmol/L were randomly assigned using serially numbered to either the intervention group (BG control by SGC) or the control group (conventional empiric BG management). The both group aim to establish the BG levels 5.8-8.9mmol/L.
Study protocol: BG measurements were performed using glucometer to test the fingertip capillary blood sample for the BG levels. As for patients with shock or required vasopressor, arterial BG was sampled to measure through the glucometer. Insulin was infused intravenously applying the standard perfusor of the ICU. Average glucose, glucose variability, SOFA score, APACHE II score, and HLA-DR were recorded. All trial-related activities were carried out until the end of the patient's ICU stay, or for a period of 72 hours. Meanwhile, enteral and parenteral nutrition was administrated to patients according to their condition.
Statistical analysis was performed on an intention-to-treat basis. The percentage of values in the target range (5.8-8.9mmol/L) was defined as primary end point for the assessment of glucose control. Data are reported as mean±SD values if not otherwise indicated. Data analysis was performed using SPSS19.0.
- Conditions
- Sepsis, Hyperglycemia, Critical Illness
- Being tested
- SGC directed glycemic control
- Medical subject headings
- Sepsis, Hyperglycemia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGC directed glycemic controlDevice
the patients' blood glucose is controlled by SGC system through insulin continuous infusion whose dosage is determinated by SGC
| Study group | Role | What they receive |
|---|---|---|
| conventional empirical glycemic control | Other | the patients' blood glucose is controlled by physician according to their experience through insulin subcutaneous injection or insulin continuous infusion whose dosage is determinated by the physician. Receives: Device: SGC directed glycemic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose variability
mean blood glucose, standard deviation (SD) for the mean glucose,minimum and maximum glucose levels
Measured: up to 3days
Secondary outcomes (1)
HLADr
Measured: up to 3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980588
- Sponsor's protocol ID
- Zhongda-ICU-SGC
- Status last verified
- Nov 2016
- First submitted
- 17 Nov 2016
- Last updated
- 2 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing SGC and Conventional Empiric Treatment for Glucose Control in Critically Ill Patients With Sepsis in ICU
- ClinicalTrials.gov ID
- NCT02980588
- Acronym / sponsor ID
- Zhongda-ICU-SGC
- Conditions
- Sepsis, Hyperglycemia, Critical Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 2 Dec 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.
Poorly glycemic control in critically ill patients can increase their mortality, while safe and efficient glucose control is laborious and time-consuming. The Space Glucose Control which is installed with eMPC(enhanced Model Predictive Control) can get the blood glucose target range safely and effectively through regulating insulin dose rate, and decrease the glucose variability. This study is a random controlled trial involving the patients with sepsis in intensive care unit in order to evaluate the difference of safety and efficacy of blood glucose control between SGC directed and conventional treatment. At last, the trial results can determine whether the Space Glucose Control can control blood glucose safely and effectively in the patients with sepsis in intensive care units.
Detailed description
Design: The study was conducted as a single-centre, open randomized controlled, parallel trial.
Study population: Adult general ICU patients with sepsis and assumed to require at least 3 days of intensive care were recruited. Patients fulfilling the inclusion criterion of glucose≥9.0 mmol/L were randomly assigned using serially numbered to either the intervention group (BG control by SGC) or the control group (conventional empiric BG management). The both group aim to establish the BG levels 5.8-8.9mmol/L.
Study protocol: BG measurements were performed using glucometer to test the fingertip capillary blood sample for the BG levels. As for patients with shock or required vasopressor, arterial BG was sampled to measure through the glucometer. Insulin was infused intravenously applying the standard perfusor of the ICU. Average glucose, glucose variability, SOFA score, APACHE II score, and HLA-DR were recorded. All trial-related activities were carried out until the end of the patient's ICU stay, or for a period of 72 hours. Meanwhile, enteral and parenteral nutrition was administrated to patients according to their condition.
Statistical analysis was performed on an intention-to-treat basis. The percentage of values in the target range (5.8-8.9mmol/L) was defined as primary end point for the assessment of glucose control. Data are reported as mean±SD values if not otherwise indicated. Data analysis was performed using SPSS19.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| conventional empirical glycemic control | Other | Device: SGC directed glycemic controlthe patients' blood glucose is controlled by physician according to their experience through insulin subcutaneous injection or insulin continuous infusion whose dosage is determinated by the physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admitted to the ICU
- At least one BG measurement 9.0mmol/L or higher
- Expected to stay in ICU ≥3 days;
- critically ill patients with sepsis
- SOFA score≤2
Key exclusion criteria (5 listed)
- Aged < 18 years;
- Admitted because of diabetic ketoacidosis or nonketotic hyperosmolar state
- Pregnant
- In a state in which death was perceived as imminent
- Without written informed consent
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 |
|---|---|---|
| SGC directed glycemic controlthe patients' blood glucose is controlled by SGC system through insulin continuous infusion whose dosage is determinated by SGC | Device | conventional empirical glycemic control |
Primary outcome
glucose variability
Time frame: up to 3days
mean blood glucose, standard deviation (SD) for the mean glucose,minimum and maximum glucose levels
1 secondary outcome
HLADr
Time frame: up to 3days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study of Sepsis and Hyperglycemia, run by Southeast University, China.
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 5 inclusion and 5 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 2 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Mo, Doctor (13914719904, momin_2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose variability (time frame: up to 3days). 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 Dec 2016.