PURPOSE: To compare the effect of intensive versus conventional blood glucose control in patients with traumatic brain injury. METHODS: In a large international randomized trial patients were randomly assigned to a target blood glucose (BG) range of either 4.5-6.0 mmol/L (intensive control) or <10 mmol/L (conventional control). Patients with traumatic brain injury (TBI) were identified at randomization and data were collected to examine the extended Glasgow outcome score (includes mortality) at 24 months. RESULTS: Of the 6104 randomized patients, 391 satisfied diagnostic criteria for TBI; 203 (51.9%) were assigned to intensive and 188 (48.1%) to conventional control; the primary outcome was available for 166 (81.8%) and 149 (79.3%) patients, respectively. The two groups had similar baseline characteristics. At 2 years 98 (58.7%) patients in the intensive group and 79 (53.0%) in the conventional group had a favorable neurological outcome (odds ratio [OR] 1.26, 95% CI 0.81-1.97; P = 0.3); 35 patients (20.9%) in the intensive group and 34 (22.8%) in the conventional group had died (OR 0.90, 95% CI 0.53-1.53; P = 0.7); moderate hypoglycemia (BG 2.3-3.9 mmol/L; 41-70 mg/dL) occurred in 160/202 (79.2%) and 17/188 (9.0%), respectively (OR 38.3, 95% CI 21.0-70.1; P < 0.0001); severe hypoglycemia (BG ≤ 2.2 mmol/L; ≤40 mg/dL) in 10 (4.9%) and 0 (0.0%), respectively (OR 20.5 95% CI 1.2-351.6, P = 0.003). CONCLUSION: Although patients with traumatic brain injury randomly assigned to intensive compared to conventional glucose control experienced moderate and severe hypoglycemia more frequently, we found no significant difference in clinically important outcomes.
RCT Entities:
PURPOSE: To compare the effect of intensive versus conventional blood glucose control in patients with traumatic brain injury. METHODS: In a large international randomized trial patients were randomly assigned to a target blood glucose (BG) range of either 4.5-6.0 mmol/L (intensive control) or <10 mmol/L (conventional control). Patients with traumatic brain injury (TBI) were identified at randomization and data were collected to examine the extended Glasgow outcome score (includes mortality) at 24 months. RESULTS: Of the 6104 randomized patients, 391 satisfied diagnostic criteria for TBI; 203 (51.9%) were assigned to intensive and 188 (48.1%) to conventional control; the primary outcome was available for 166 (81.8%) and 149 (79.3%) patients, respectively. The two groups had similar baseline characteristics. At 2 years 98 (58.7%) patients in the intensive group and 79 (53.0%) in the conventional group had a favorable neurological outcome (odds ratio [OR] 1.26, 95% CI 0.81-1.97; P = 0.3); 35 patients (20.9%) in the intensive group and 34 (22.8%) in the conventional group had died (OR 0.90, 95% CI 0.53-1.53; P = 0.7); moderate hypoglycemia (BG 2.3-3.9 mmol/L; 41-70 mg/dL) occurred in 160/202 (79.2%) and 17/188 (9.0%), respectively (OR 38.3, 95% CI 21.0-70.1; P < 0.0001); severe hypoglycemia (BG ≤ 2.2 mmol/L; ≤40 mg/dL) in 10 (4.9%) and 0 (0.0%), respectively (OR 20.5 95% CI 1.2-351.6, P = 0.003). CONCLUSION: Although patients with traumatic brain injury randomly assigned to intensive compared to conventional glucose control experienced moderate and severe hypoglycemia more frequently, we found no significant difference in clinically important outcomes.
Authors: Paul Vespa; Robert Boonyaputthikul; David L McArthur; Chad Miller; Maria Etchepare; Marvin Bergsneider; Thomas Glenn; Neil Martin; David Hovda Journal: Crit Care Med Date: 2006-03 Impact factor: 7.598
Authors: Yaseen M Arabi; Ousama C Dabbagh; Hani M Tamim; Abdullah A Al-Shimemeri; Ziad A Memish; Samir H Haddad; Sofia J Syed; Hema R Giridhar; Asgar H Rishu; Mouhamad O Al-Daker; Salim H Kahoul; Riette J Britts; Maram H Sakkijha Journal: Crit Care Med Date: 2008-12 Impact factor: 7.598
Authors: Moritoki Egi; James S Krinsley; Paula Maurer; Devendra N Amin; Tomoyuki Kanazawa; Shruti Ghandi; Kiyoshi Morita; Michael Bailey; Rinaldo Bellomo Journal: Intensive Care Med Date: 2016-02-03 Impact factor: 17.440
Authors: Roland N Dickerson; Vanessa J Kumpf; Allison B Blackmer; Angela L Bingham; Anne M Tucker; Joseph V Ybarra; Michael D Kraft; Todd W Canada Journal: Hosp Pharm Date: 2016-07
Authors: Kelly C Vranas; Jennifer Y Scott; Omar Badawi; Michael O Harhay; Christopher G Slatore; Donald R Sullivan; Meeta Prasad Kerlin Journal: Chest Date: 2020-03-27 Impact factor: 9.410