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

Sepsis Clinical Trial

Official title:

Comparing SGC and Conventional Empiric Treatment for Glucose Control in Critically Ill Patients With Sepsis in ICU

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02980588
• Other study ID #: Zhongda-ICU-SGC
• Status: Not yet recruiting
• Phase: N/A
• First received: November 17, 2016
• Last updated: November 29, 2016
• Start date: December 2016
• Est. completion date: September 2017

Study information

• Verified date: November 2016
• Source: Southeast University, China
• Contact: Min Mo, Doctor
• Phone: 13914719904
• Email: momin_2002[@]163.com
• Is FDA regulated: No
• Health authority: China: Jiangsu Province Health Department
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Hyperglycemia
• Sepsis
• Toxemia

Intervention

Device:
• SGC directed glycemic control
the patients' blood glucose is controlled by SGC system through insulin continuous infusion whose dosage is determinated by SGC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose variability	mean blood glucose, standard deviation (SD) for the mean glucose,minimum and maximum glucose levels	up to 3days	No
Secondary	HLADr		up to 3days	No