A Phase 4 interventional study of Insulin in Brain Injuries and Hyperglycemia, sponsored by Lianyungang Oriental Hospital. Status unknown at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-07-23.
Sponsored by Lianyungang Oriental Hospital · Phase 4, Interventional, and Treatment
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.
Hyperglycemia induced by traumatic brain injury is directly correlated with patient prognosis. Previous studies showed that if blood glucose could be controlled \< 6.11 mmol/L, prognosis would be good and mortality would be decreased by approximately 50%. Moreover, the incidence of ICU-related complications, especially infection, was obviously reduced. A study concerning severe traumatic brain injury analyzed the recovery of patients at 18 days, 3 months and 1 year after trauma, and demonstrated that the prognosis of patients with blood glucose levels \< 11.1 mmol/L within 24 hours of hospital admission was apparently better than those whose blood glucose levels were > 11.1 mmol/L. Hyperglycemia occurred after traumatic brain injury and was treated with intensive insulin therapy. Thus, blood glucose levels were controlled between 4.4 and 6.1 mmol/L, which noticeably shortened insulin use and decreased the incidence of multiple organ dysfunction and mortality of patients with traumatic brain injury.
It is well known that hyperglycemia will appear after traumatic brain injury. However, there are few clinical studies addressing continuous dynamic monitoring of blood glucose of traumatic brain injury patients and the relationship between changes in blood glucose and the degree of traumatic brain injury. Insulin therapy for reducing injury to secondary nerve cells after traumatic brain injury and for improving functional prognosis has also not been explored.
When blood glucose level is > 7.0 mmol/L as measured twice by rapid examination within 2 hours of hospital admission, patients with hyperglycemia after severe closed traumatic brain injury will be randomly divided into the intensive therapy group and nonintensive therapy group according to the random number table.
Patients in both groups will be treated using the protocol as follows.
Blood glucose measurement: Capillary blood will be obtained from the tip of the ring finger to measure blood glucose. For a period, the blood should be collected from the same finger to make sure an accurate measurement occurs. When blood glucose of a patient undergoing transfusion was measured, blood should be collected from the tip of the finger of the limb without transfusion to ensure the accuracy of measurement.
Monitoring of target blood glucose: insulin dose will be selected in accordance with the Yale Insulin Infusion Protocol.
2,112 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
This study's planned enrollment of 144 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →This is the only study on the registry with Lianyungang Oriental Hospital as lead sponsor.
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Exclusion Criteria:
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
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
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
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
Also known as: Insulin Injection(10mL:400u), manufactured by Wanbang Biochemical Pharmaceutical Co., Ltd. Lot No. 1307230, No. 1302225, No. 1307210.
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.
Time frame: 4 weeks
Mortality
Percentage of patients who die during hospitalization period, at 1 week after surgery, at 2 weeks after surgery, and at 3 months after injury.
Time frame: 6 months after surgery
Evaluation of activity of daily living
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.
Time frame: 2 weeks after hospital admission, 3 months and 6 months after injury
Evaluation of severity of patient's condition
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.
Time frame: An expected time of 7 days
CT monitoring of morphological changes in the brain
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.
Time frame: Until 14 days after surgery
Monitoring of changes in cerebrospinal fluid
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.
Time frame: 1 week after surgery
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