CONTEXT: Prehospital hypertonic saline (HTS) resuscitation of patients with traumatic brain injury (TBI) may increase survival but whether HTS improves neurological outcomes is unknown. OBJECTIVE: To determine whether prehospital resuscitation with intravenous HTS improves long-term neurological outcome in patients with severe TBI compared with resuscitation with conventional fluids. DESIGN, SETTING, AND PATIENTS: Double-blind, randomized controlled trial of 229 patients with TBI who were comatose (Glasgow Coma Scale score, <9) and hypotensive (systolic blood pressure, <100 mm Hg). The patients were enrolled between December 14, 1998, and April 9, 2002, in Melbourne, Australia. INTERVENTIONS: Patients were randomly assigned to receive a rapid intravenous infusion of either 250 mL of 7.5% saline (n = 114) or 250 mL of Ringer's lactate solution (n = 115; controls) in addition to conventional intravenous fluid and resuscitation protocols administered by paramedics. Treatment allocation was concealed. MAIN OUTCOME MEASURE: Neurological function at 6 months, measured by the extended Glasgow Outcome Score (GOSE). RESULTS: Primary outcomes were obtained in 226 (99%) of 229 patients enrolled. Baseline characteristics of the groups were equivalent. At hospital admission, the mean serum sodium level was 149 mEq/L for HTS patients vs 141 mEq/L for controls (P<.001). The proportion of patients surviving to hospital discharge was similar in both groups (n = 63 [55%] for HTS group and n = 57 [50%] for controls; P =.32); at 6 months, survival rates were n = 62 (55%) in the HTS group and n = 53 (47%) in the control group (P =.23). At 6 months, the median (interquartile range) GOSE was 5 (3-6) in the HTS group vs 5 (5-6) in the control group (P =.45). There was no significant difference between the groups in favorable outcomes (moderate disability and good outcome survivors [GOSE of 5-8]) (risk ratio, 0.99; 95% confidence interval, 0.76-1.30; P =.96) or in any other measure of postinjury neurological function. CONCLUSION: In this study, patients with hypotension and severe TBI who receivedprehospital resuscitation with HTS had almost identical neurological function 6 months after injury as patients who received conventional fluid.
RCT Entities:
CONTEXT: Prehospital hypertonicsaline (HTS) resuscitation of patients with traumatic brain injury (TBI) may increase survival but whether HTS improves neurological outcomes is unknown. OBJECTIVE: To determine whether prehospital resuscitation with intravenous HTS improves long-term neurological outcome in patients with severe TBI compared with resuscitation with conventional fluids. DESIGN, SETTING, AND PATIENTS: Double-blind, randomized controlled trial of 229 patients with TBI who were comatose (Glasgow Coma Scale score, <9) and hypotensive (systolic blood pressure, <100 mm Hg). The patients were enrolled between December 14, 1998, and April 9, 2002, in Melbourne, Australia. INTERVENTIONS:Patients were randomly assigned to receive a rapid intravenous infusion of either 250 mL of 7.5% saline (n = 114) or 250 mL of Ringer's lactate solution (n = 115; controls) in addition to conventional intravenous fluid and resuscitation protocols administered by paramedics. Treatment allocation was concealed. MAIN OUTCOME MEASURE: Neurological function at 6 months, measured by the extended Glasgow Outcome Score (GOSE). RESULTS: Primary outcomes were obtained in 226 (99%) of 229 patients enrolled. Baseline characteristics of the groups were equivalent. At hospital admission, the mean serum sodium level was 149 mEq/L for HTS patients vs 141 mEq/L for controls (P<.001). The proportion of patients surviving to hospital discharge was similar in both groups (n = 63 [55%] for HTS group and n = 57 [50%] for controls; P =.32); at 6 months, survival rates were n = 62 (55%) in the HTS group and n = 53 (47%) in the control group (P =.23). At 6 months, the median (interquartile range) GOSE was 5 (3-6) in the HTS group vs 5 (5-6) in the control group (P =.45). There was no significant difference between the groups in favorable outcomes (moderate disability and good outcome survivors [GOSE of 5-8]) (risk ratio, 0.99; 95% confidence interval, 0.76-1.30; P =.96) or in any other measure of postinjury neurological function. CONCLUSION: In this study, patients with hypotension and severe TBI who received prehospital resuscitation with HTS had almost identical neurological function 6 months after injury as patients who received conventional fluid.
Authors: Eileen M Bulger; Susanne May; Karen J Brasel; Martin Schreiber; Jeffrey D Kerby; Samuel A Tisherman; Craig Newgard; Arthur Slutsky; Raul Coimbra; Scott Emerson; Joseph P Minei; Berit Bardarson; Peter Kudenchuk; Andrew Baker; Jim Christenson; Ahamed Idris; Daniel Davis; Timothy C Fabian; Tom P Aufderheide; Clifton Callaway; Carolyn Williams; Jane Banek; Christian Vaillancourt; Rardi van Heest; George Sopko; J Steven Hata; David B Hoyt Journal: JAMA Date: 2010-10-06 Impact factor: 56.272
Authors: Monica E Kleinman; Allan R de Caen; Leon Chameides; Dianne L Atkins; Robert A Berg; Marc D Berg; Farhan Bhanji; Dominique Biarent; Robert Bingham; Ashraf H Coovadia; Mary Fran Hazinski; Robert W Hickey; Vinay M Nadkarni; Amelia G Reis; Antonio Rodriguez-Nunez; James Tibballs; Arno L Zaritsky; David Zideman Journal: Circulation Date: 2010-10-19 Impact factor: 29.690
Authors: D Rörtgen; A Schaumberg; M Skorning; S Bergrath; S K Beckers; M Coburn; J C Brokmann; H Fischermann; M Nieveler; R Rossaint Journal: Anaesthesist Date: 2010-12-04 Impact factor: 1.041
Authors: Monica E Kleinman; Allan R de Caen; Leon Chameides; Dianne L Atkins; Robert A Berg; Marc D Berg; Farhan Bhanji; Dominique Biarent; Robert Bingham; Ashraf H Coovadia; Mary Fran Hazinski; Robert W Hickey; Vinay M Nadkarni; Amelia G Reis; Antonio Rodriguez-Nunez; James Tibballs; Arno L Zaritsky; David Zideman Journal: Pediatrics Date: 2010-10-18 Impact factor: 7.124
Authors: Sandro B Rizoli; Shawn G Rhind; Pang N Shek; Kenji Inaba; Dennis Filips; Homer Tien; Fred Brenneman; Ori Rotstein Journal: Ann Surg Date: 2006-01 Impact factor: 12.969
Authors: D James Cooper; Alistair D Nichol; Michael Bailey; Stephen Bernard; Peter A Cameron; Sébastien Pili-Floury; Andrew Forbes; Dashiell Gantner; Alisa M Higgins; Olivier Huet; Jessica Kasza; Lynne Murray; Lynette Newby; Jeffrey J Presneill; Stephen Rashford; Jeffrey V Rosenfeld; Michael Stephenson; Shirley Vallance; Dinesh Varma; Steven A R Webb; Tony Trapani; Colin McArthur Journal: JAMA Date: 2018-12-04 Impact factor: 56.272