A Trial Comparing SGC and Conventional Empiric Treatment for Glucose Control in Critically Ill Patients With Mechanical Ventilation in ICU
A Randomized Controlled Trial Comparing SGC and Conventional Empiric Treatment for Glucose Control in Critically Ill Patients With Mechanical Ventilation in ICU
1 other identifier
interventional
46
1 country
1
Brief Summary
Poor glycemic control in critically ill patients can increase their mortality, while safe and efficient glucose control is laborious and time-consuming. The Space GlucoseControl which is installed with eMPC(enhanced Model Predictive Control) can get the blood glucose target range safely and effectively through regulating insulin dose rate. This study is a random controlled trial involving the patients with mechanical ventilation 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 GlucoseControl can control blood glucose safely and effectively in the patients with mechanical ventilation in intensive care units.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 18, 2015
CompletedFirst Posted
Study publicly available on registry
July 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJuly 8, 2015
May 1, 2015
10 months
May 18, 2015
July 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
the percentage of time within the predefined glucose the target range(5.8-8.9mmol /l)
6 months
Study Arms (2)
conventional empirical glycemic control
ACTIVE COMPARATORthe 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.
SGC directed glycemic control
EXPERIMENTALthe patients' blood glucose is controlled by SGC system through insulin continuous infusion whose dosage is determinated by SGC.
Interventions
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.
the patients' blood glucose is controlled by SGC system through insulin continuous infusion whose dosage is determinated by SGC.
Eligibility Criteria
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;
- Mechanical ventilation
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MICU of Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (1)
Xu B, Jiang W, Wang CY, Weng L, Hu XY, Peng JM, Du B. Comparison of Space Glucose Control and Routine Glucose Management Protocol for Glycemic Control in Critically Ill Patients: A Prospective, Randomized Clinical Study. Chin Med J (Engl). 2017 Sep 5;130(17):2041-2049. doi: 10.4103/0366-6999.213422.
PMID: 28836546DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bin Du, Dr
MICU of Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2015
First Posted
July 8, 2015
Study Start
October 1, 2014
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
July 8, 2015
Record last verified: 2015-05