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

NCT02980588 | Unknown

• 1 other identifier: Zhongda-ICU-SGC
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis; Hyperglycemia; Critical Illness

Outcome Measures

Primary Outcomes (1)

• glucose variability

  mean blood glucose, standard deviation (SD) for the mean glucose,minimum and maximum glucose levels

  up to 3days

Secondary Outcomes (1)

• HLADr

  up to 3days

Study Arms (1)

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.

Device: SGC directed glycemic control

Interventions

SGC directed glycemic control DEVICE

the patients' blood glucose is controlled by SGC system through insulin continuous infusion whose dosage is determinated by SGC

conventional empirical glycemic control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southeast University, China: lead

MeSH Terms

Conditions

Sepsis; Hyperglycemia; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes

Central Study Contacts

Min Mo, Doctor

CONTACT

13914719904; momin_2002@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dcotor

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 2, 2016
• Study Start: December 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 2, 2016

Record last verified: 2016-11