Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intensive Versus Nonintensive Insulin Therapy for Hyperglycemia After Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02161055
Recruitment Status : Unknown
Verified July 2014 by Wenxue Wang, Lianyungang Oriental Hospital.
Recruitment status was:  Recruiting
First Posted : June 11, 2014
Last Update Posted : July 23, 2014
Sponsor:
Collaborator:
The First People's Hospital of Lianyungang
Information provided by (Responsible Party):
Wenxue Wang, Lianyungang Oriental Hospital

Brief Summary:
An increase in blood glucose is a common clinical symptom in patients following traumatic brain injury. Studies confirm that death after traumatic brain injury was not only associated with nerve injury, but also correlated with abnormal physiological and metabolic reactions. Hyperglycemia is a manifestation of physiological and metabolic disorders after traumatic brain injury. Traumatic brain injury induced hyperglycemia, and then aggravated secondary injury to the brain. Therefore, it is of important clinical significance to study the treatment of hyperglycemia after traumatic brain injury.

Condition or disease Intervention/treatment Phase
Brain Injuries Hyperglycemia Drug: Insulin Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Study of Intensive Versus Nonintensive Insulin Therapy for Hyperglycemia After Traumatic Brain Injury
Study Start Date : June 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Strict control group

Intensive insulin therapy: Keep Target blood glucose levels between 4.4-7.0 mmol/L;

Blood glucose levels were monitored and controlled using the Yale Insulin Infusion Protocol. Rapid blood glucose levels were monitored once every 2 hours.

Drug: Insulin

Insulin dose was selected in accordance with the Yale Insulin Infusion Protocol.

• Amount of insulin (u) = [fasting blood glucose (mmol/L) × 18-100] × 10 × body weight (kilogram) × 0.6 ÷ 1000 ÷ 2

Other Name: Insulin Injection(10mL:400u), manufactured by Wanbang Biochemical Pharmaceutical Co., Ltd. Lot No. 1307230, No. 1302225, No. 1307210.

Experimental: Moderate control group

Intensive insulin therapy: Keep target blood glucose levels between 7.1 and 10.0 mmol/L.

Blood glucose levels were monitored and controlled using the Yale Insulin Infusion Protocol. Rapid blood glucose levels were monitored once every 2 hours

Drug: Insulin

Insulin dose was selected in accordance with the Yale Insulin Infusion Protocol.

• Amount of insulin (u) = [fasting blood glucose (mmol/L) × 18-100] × 10 × body weight (kilogram) × 0.6 ÷ 1000 ÷ 2

Other Name: Insulin Injection(10mL:400u), manufactured by Wanbang Biochemical Pharmaceutical Co., Ltd. Lot No. 1307230, No. 1302225, No. 1307210.

Experimental: Slight control group

Intensive insulin therapy: Keep target blood glucose levels between 10.1 and 13.0 mmol/L.

Blood glucose levels were monitored and controlled using the Yale Insulin Infusion Protocol. Rapid blood glucose levels were monitored once every 2 hours.

Drug: Insulin

Insulin dose was selected in accordance with the Yale Insulin Infusion Protocol.

• Amount of insulin (u) = [fasting blood glucose (mmol/L) × 18-100] × 10 × body weight (kilogram) × 0.6 ÷ 1000 ÷ 2

Other Name: Insulin Injection(10mL:400u), manufactured by Wanbang Biochemical Pharmaceutical Co., Ltd. Lot No. 1307230, No. 1302225, No. 1307210.

Active Comparator: Non-intensive insulin therapy
Rapid blood glucose levels were measured once every 2 hours. When blood glucose levels were ≤ 13.0 mmol/L, no intervention was performed; When blood glucose levels were > 13.0 mmol/L, regular insulin was subcutaneously injected separately. During fasting, insulin was injected once every 8 hours. During venous or enteral nutrition infusion, insulin was infused at 30 minutes before nutrition infusion. When blood glucose levels were ≤ 13.0 mmol/L, insulin infusion was terminated.
Drug: Insulin

Insulin dose was selected in accordance with the Yale Insulin Infusion Protocol.

• Amount of insulin (u) = [fasting blood glucose (mmol/L) × 18-100] × 10 × body weight (kilogram) × 0.6 ÷ 1000 ÷ 2

Other Name: Insulin Injection(10mL:400u), manufactured by Wanbang Biochemical Pharmaceutical Co., Ltd. Lot No. 1307230, No. 1302225, No. 1307210.




Primary Outcome Measures :
  1. Monitoring of target blood glucose [ Time Frame: 4 weeks ]
    Within 1 week of hospitalization, rapid blood glucose levels will be recorded once every 2 hours in each group. Glycosylated serum protein levels will be measured once a week, for 4 consecutive weeks. This index reflects the mean blood glucose levels of 2 - 3 weeks.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 6 months after surgery ]
    Percentage of patients who die during hospitalization period, at 1 week after surgery, at 2 weeks after surgery, and at 3 months after injury.

  2. Evaluation of activity of daily living [ Time Frame: 2 weeks after hospital admission, 3 months and 6 months after injury ]

    At 2 weeks after hospital admission, Modified Rankin Scale and Glasgow outcome score will be applied.

    During follow-up at 3 months after injury, Barthel index, Glasgow outcome score and Modified Rankin Scale will be employed.

    During follow-up at 6 months after injury, Barthel index and Glasgow outcome score will be used.



Other Outcome Measures:
  1. Evaluation of severity of patient's condition [ Time Frame: An expected time of 7 days ]
    Glasgow coma score will evaluate the severity of patient's condition, as will a recording sheet evaluating the patient's condition at hospital admission. Acute Physiology and Chronic Health Evaluation II will occur on each subsequent day in ICU.

  2. CT monitoring of morphological changes in the brain [ Time Frame: Until 14 days after surgery ]
    CT scans will monitor the morphological changes in the brain on hospital admission, preoperation, 1-3 days postoperation, 7 days postoperation, and 14 days postoperation.

  3. Monitoring of changes in cerebrospinal fluid [ Time Frame: 1 week after surgery ]
    Cerebrospinal fluid will be obtained for biochemical analysis and cell culture. Cerebrospinal fluid will be collected during surgery, and obtained at 1 week after surgery by lumbar puncture.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe closed traumatic brain injury diagnosed in the clinic;
  • Severe closed traumatic brain injury verified by CT examinations;
  • Patients who are in accordance with the indications of craniotomy for severe traumatic brain injury;
  • Blood glucose levels > 7.0 mmol/L measured twice by rapid examination within 2 hours of hospital admission;
  • Glasgow coma score between 3 and 8;
  • At the age of 18 - 80 years old;
  • Irrespective of gender.

Exclusion Criteria:

  • At the age of < 18 years old or > 80 years old;
  • Glasgow coma score > 8;
  • Patients combined with multiple site damage;
  • Hemodialysis-dependent patients combined with diabetic nephropathy;
  • Patients with nervous system disease before traumatic brain injury;
  • Patients with a history of diabetes before suffering from a traumatic brain injury.

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): NCT02161055


Contacts
Layout table for location contacts
Contact: Wenxue Wang, M.D., Ph.D. +8615151268106 731545804@qq.com

Locations
Layout table for location information
China, Jiangsu
Lianyungang Oriental Hospital Recruiting
Lianyungang, Jiangsu, China, 222042
Contact: Wenxue Wang, M.D., Ph.D.    +8615151268106    731545804@qq.com   
Principal Investigator: Wenxue Wang, M.D., Ph.D.         
The First People's Hospital of Lianyungang Recruiting
Lianyungang, Jiangsu, China
Contact: Aimin Li, M.D.         
Principal Investigator: Aimin Li, M.D.         
Sponsors and Collaborators
Lianyungang Oriental Hospital
The First People's Hospital of Lianyungang
Investigators
Layout table for investigator information
Principal Investigator: Wenxue Wang, M.D., Ph.D. Lianyungang Oriental Hospital

Layout table for additonal information
Responsible Party: Wenxue Wang, Professor, Director of the Department of Neurosurgery, Lianyungang Oriental Hospital
ClinicalTrials.gov Identifier: NCT02161055     History of Changes
Other Study ID Numbers: LYG-1401-WW
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014
Keywords provided by Wenxue Wang, Lianyungang Oriental Hospital:
Insulin
Hyperglycemia
Postoperative Mortality
Intensive insulin therapy
Non-intensive insulin therapy
Brain Injuries
Wounds and Injuries
Craniocerebral Trauma
Trauma, Nervous System
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Hyperglycemia
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs