Comparison of intensive insulin therapy versus conventional glucose control in traumatic brain injury patients on parenteral nutrition: A pilot randomized clinical trial

Background: Parenteral nutrition (PN) is a valuable life saving intervention, which can improve the nutritional status of hospitalized malnourished patients. PN is associated with complications including hyperglycemia. This study was conducted to compare two methods of blood glucose control in traumatic brain injury patients on PN. Materials and Methods: A randomized, open-label, controlled trial with blinded end point assessment was designed. Traumatic brain injury patients (GCS = 4-9) on PN, without diabetes, pancreatitis, liver disease, kidney complication, were participated. Patients were randomly assigned to receive continuous insulin infusion to maintain glucose levels between 4.4 mmol/l (80 mg/dl) and 6.6 mmol/l (120 mg/dl) (n = 13) or conventional treatment (n = 13). Patients in the conventional group were not received insulin unless glucose levels were greater than 10 mmol/l (>180 mg/dl). These methods were done to maintain normoglycemia in ICU. The primary outcome was hypo/hyperglycemic episodes. Other factors such as C-reactive protein, blood electrolytes, liver function tests, lipid profile and mid-arm circumference were compared. Results: Mean glucose concentration were significantly lower in IIT group (118 +/- 28 mg/dl) vs conventional group (210 +/- 31 mg/dl) (P < 0.01). No hypoglycemic episode occurred in two groups. Triglyceride (P = 0.02) and C-reactive protein (P = 0.001) was decreased in the IIT group, significantly. There were also significant differences in the electrolytes, with magnesium and phosphorus being lower in the IIT group (P = 0.05). Conclusion: In this pilot study, blood glucose level, CRP and TG were lower in IIT group. Further data collection is warranted to reach definitive conclusions.