Randomized Controlled Clinical Study of Intensive Versus Nonintensive Insulin Therapy for Hyperglycemia After Traumatic Brain Injury
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Monitoring of target blood glucose
研究概览
简要总结
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.
详细描述
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.
- Craniotomy for traumatic brain injury to mainly decompress and remove hematoma. Standard trauma craniotomy and incision of trachea will be performed.
- During the operation, all patients will undergo ventricular puncture. Cerebrospinal fluid will be obtained for biochemical analysis and cell culture.
- All patients will be closely monitored in the ICU of the Department of Neurosurgery.
- Therapeutic protocols for severe traumatic brain injury will be used.
- Glucocorticoid can cause disorders of glucose metabolism, so glucocorticoids can not be regularly applied in these two groups.
- When glucose was injected into the vein, insulin was added at the proportion of 5:1 to eliminate glucose effects on blood glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Insulin (Drug)
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
干预措施: Insulin (Drug)
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.
干预措施: Insulin (Drug)
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.
干预措施: Insulin (Drug)
结局指标
主要结局
Monitoring of target blood glucose
时间窗: 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.
次要结局
- Mortality(6 months after surgery)
- Evaluation of activity of daily living(2 weeks after hospital admission, 3 months and 6 months after injury)
研究者
Wenxue Wang
Professor, Director of the Department of Neurosurgery
Lianyungang Oriental Hospital