| Backgrouds More and more evidences prove that sustained hyperglycemia is related to the morbidity and mortality of patients with severe traumatic brain injury. And it is associated with the acidosis of brain tissue. Furthermore, sustained hyperglycemia can increase the release of the inflammatory cytokines and aggravate the injury of the patients with traumatic brain injury. Among critical ill patients, including patients with severe traumatic brain injury, even though they don't have the history of diabetes mellitus, hyperglycemia and insulin resistance are very ofen. It is found that intensive insulin therapy strictly maintaining the blood glucose within the normal range may have benefits on these patients. Evidences also show that intensive insulin therapy can decrease the morbidity and mortality. Another trial focusing on the effect of intensive insulin therapy in treating patients with cardiosurgery postoperatively found that it can reduce the complication (infection) and mortality. However, it may increase the possibility of hypoglycemia during period of intensive insulin therapy. The application of intensive insulin therapy is controversial in clinic. Therefore, more standard and specific researches are needed to evaluate the safety and effectiveness of intensive insulin therapy.Objectives To investigate the safety and effectiveness of intensive insulin therapy on treat severe traumatic brain injury. And evaluate the impact of an intensive insulin therapy and conventional glucose control protocol during staying in neurological intensive care unit (NICU) on infection rate, days in NICU, in-hospital mortality and long-term neurological outcome in severe traumatic brain injury patients.Methods At the time of admission,258 patients were diagnoses as severe traumatic brain injury to the neurosurgical intensive care unit. Those who were participating in other trials, moribund or whom there were do-not-resuscitate orders were excluded.A total of 202 patients (Glasgow Coma Scale score 3-8) admitted to NICU were prospectively enrolled and randomly assigned either to conventional insulin therapy or to intensive insulin therapy. Patients in intensive glucose control group (n= 103) received continuous insulin infusion to maintain glucose levels between 4.4 mmol/l and 6.1 mmol/1. Patients in the conventional treatment group (n= 99) were not given insulin unless glucose levels were greater than 11.1 mmol/l. More frequent blood glucose measurements were performed whenever the attending physician or nurse considered them necessary and whenever there had been a steep rise or fall in the blood glucose level on the previous reading. Both groups were treated with insulin infusion to maintain normoglycemia after leaving NICU. Comparison was made against conventional insulin therapy using a randomized trial design. The events of hypoglycemia are monitored. The outcomes include NICU infection rate, duration of ICU stay, in-hospital mortality rate, neurologic outcome and overall mortality at 6 months follow-up.Results The event of the hypoglycemia is monitored in intensive group and conventional group (3.9% vs.3.0%, P>0.05). The infection rate during the study was significantly higher in patients who received conventional insulin therapy than that in patients who received intensive insulin therapy (44.4% vs.30.1%; P<0.05). The days stay in NICU was shorter in intensive insulin control group than that in conventional therapy group [4.1 days vs.5.5 days (medians) P<0.05]. The in-hospital mortality during the study was similar in conventional and intensive therapy groups (28 of 99,28.3% vs.30 of 103,29.1% in the conventional and intensive insulin therapy groups; P<0.05). Overall mortality rates at 6 months follow-up were similar in the 2 groups (52 of 96,54.2% vs.53 of 99,53.5%; P>0.05). The neurologic outcome according to Glasgow Outcome Score (GOS) at 6 months (GOS 5 and 4) was better in the intensive insulin therapy group (35 of 99,35.4%) than that in the conventional therapy group (21 of 96,21.9%, P<0.05).Conclusion According to results to this trial, intensive insulin therapy on treating patients with severe traumatic injury is safe. Intensive insulin therapy can decrease the infection rate; reduce the days staying in NICU; improve the neurologic outcome; but has no effects on in-hospital and overall mortality... |
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