NCT02161055

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2014

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 23, 2014

Status Verified

July 1, 2014

Enrollment Period

2 years

First QC Date

June 5, 2014

Last Update Submit

July 22, 2014

Conditions

Brain InjuriesHyperglycemia

Keywords

InsulinHyperglycemiaPostoperative MortalityIntensive insulin therapyNon-intensive insulin therapyBrain InjuriesWounds and InjuriesCraniocerebral TraumaTrauma, Nervous System

Outcome Measures

Primary Outcomes (1)

  • Monitoring of target blood glucose

    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.

    4 weeks

Secondary Outcomes (2)

  • Mortality

    6 months after surgery

  • Evaluation of activity of daily living

    2 weeks after hospital admission, 3 months and 6 months after injury

Other Outcomes (3)

  • Evaluation of severity of patient's condition

    An expected time of 7 days

  • CT monitoring of morphological changes in the brain

    Until 14 days after surgery

  • Monitoring of changes in cerebrospinal fluid

    1 week after surgery

Study Arms (4)

Strict control group

EXPERIMENTAL

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

Moderate control group

EXPERIMENTAL

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

Slight control group

EXPERIMENTAL

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

Non-intensive insulin therapy

ACTIVE COMPARATOR

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

Interventions

InsulinDRUG

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

Also known as: Insulin Injection(10mL:400u), manufactured by Wanbang Biochemical Pharmaceutical Co., Ltd. Lot No. 1307230, No. 1302225, No. 1307210.
Moderate control groupNon-intensive insulin therapySlight control groupStrict control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lianyungang Oriental Hospital

Lianyungang, Jiangsu, 222042, China

RECRUITING

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

RECRUITING

Related Publications (1)

  • Yuan T, He H, Liu Y, Wang J, Kang X, Fu G, Xie F, Li A, Chen J, Wang W. Association between blood glucose levels and Glasgow Outcome Score in patients with traumatic brain injury: secondary analysis of a randomized trial. Trials. 2022 Jan 15;23(1):38. doi: 10.1186/s13063-022-06005-5.

    PMID: 35033158DERIVED

MeSH Terms

Conditions

Brain InjuriesHyperglycemiaInsulin ResistanceWounds and InjuriesCraniocerebral TraumaTrauma, Nervous System

Interventions

Insulin

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Wenxue Wang, M.D., Ph.D.

    Lianyungang Oriental Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenxue Wang, M.D., Ph.D.

CONTACT

+8615151268106731545804@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director of the Department of Neurosurgery

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 11, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

July 23, 2014

Record last verified: 2014-07

Locations

CN(2)