Sepsis Clinical Trial
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.
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
glucoseā„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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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