The Effects of SGC on Glucose Control in Critically Ill Patients With Sepsis

Not Applicable

• Conditions: Sepsis; Critical Illness; Hyperglycemia
• Interventions: Device: SGC directed glycemic control

• Registration Number: NCT02980588
• Lead Sponsor: Southeast University, China

Brief 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 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 Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-29
• Last Update Submitted: 2016-11-29
• Study Start: 2016-12
• Study First Posted: 2016-12-02
• Last Update Posted: 2016-12-02
• Primary Completion: 2017-05
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Admitted to the ICU
2. At least one BG measurement 9.0mmol/L or higher
3. Expected to stay in ICU ≥3 days;
4. critically ill patients with sepsis
5. SOFA score≤2

Exclusion Criteria

1. Aged < 18 years;
2. Admitted because of diabetic ketoacidosis or nonketotic hyperosmolar state
3. Pregnant
4. In a state in which death was perceived as imminent
5. Without written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
conventional empirical glycemic control	SGC directed glycemic control	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.

Primary Outcome Measures

Name	Time	Method
glucose variability	up to 3days	mean blood glucose, standard deviation (SD) for the mean glucose,minimum and maximum glucose levels

Secondary Outcome Measures

Name	Time	Method
HLADr	up to 3days