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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02491346
• Other study ID #: MICU_2014-11
• Status: Recruiting
• Phase: Phase 4
• First received: May 18, 2015
• Last updated: July 7, 2015
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: May 2015
• Source: Peking Union Medical College Hospital
• Contact: Bin Du, Dr.
• Phone: 86-010-69155046
• Email: dubin98[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology CommissionChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• 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. 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Hyperglycemia
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.
• 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
China	MICU of Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of time within the predefined glucose the target range(5.8-8.9mmol /l)		6 months	Yes