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A Trial Comparing SGC and Conventional Empiric Treatment for Glucose Control in Critically Ill Patients With Mechanical Ventilation in ICU

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ClinicalTrials.gov Identifier: NCT02491346
Recruitment Status : Unknown
Verified May 2015 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : July 8, 2015
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Respiratory Failure Critical Illness Procedure: conventional empirical glycemic control Procedure: SGC directed glycemic control Phase 4

Detailed Description:

Design: The study was conducted as a single-centre, open randomized controlled, parallel trial.

Study population: Adult medical ICU patients who were mechanically ventilated and assumed to require at least 3 days of intensive care were recruited. Patients fulfilling the inclusion criterion of glucose≥9.0 mM 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 5.8-8.9mM.

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 [40 IU of Actrapid HM (Wanbang Biopharmaceuticals, Jiangsu province, China)/40ml of 0.9% sodium chloride] was infused intravenously applying the standard perfusor of the ICU (Perfusor®Space, B. Braun Melsungen AG, Melsungen, Germany). 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 (5.8-8.9mM) 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing SGC and Conventional Empiric Treatment for Glucose Control in Critically Ill Patients With Mechanical Ventilation in ICU
Study Start Date : October 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : September 2015

Arm Intervention/treatment
Active Comparator: conventional empirical 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.
Procedure: conventional empirical 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.
Other Name: comparator group

Experimental: SGC directed glycemic control
the patients' blood glucose is controlled by SGC system through insulin continuous infusion whose dosage is determinated by SGC.
Procedure: SGC directed glycemic control
the patients' blood glucose is controlled by SGC system through insulin continuous infusion whose dosage is determinated by SGC.
Other Name: SGC group




Primary Outcome Measures :
  1. the percentage of time within the predefined glucose the target range(5.8-8.9mmol /l) [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Mechanical ventilation

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491346


Contacts
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Contact: Bin Du, Dr. 86-010-69155046 dubin98@gmail.com

Locations
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China, Beijing
MICU of Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Bin Du, Dr    86-010-69155046    dubin98@gmail.com   
Principal Investigator: Bin Du, Doctor         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Bin Du, Dr MICU of Peking Union Medical College Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02491346     History of Changes
Other Study ID Numbers: MICU_2014-11
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hyperglycemia
Critical Illness
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs