Trial reportJAMA2010
Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial.
Trial report in JAMA, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 91 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 3 Study of Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)
Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study
Who cites it
91 citing papers in PubMed, 8 syntheses or guidelines pooled it, 305 citations in OpenAlex.
- Randomised controlled trials in pre-hospital trauma: a systematic mapping review.Scandinavian journal of trauma, resuscitation and emergency medicine · 2021Pooled it
- Guidelines for the Acute Treatment of Cerebral Edema in Neurocritical Care Patients.Neurocritical care · 2020Guideline
- Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys.JAMA network open · 2019Pooled it
- Colloids versus crystalloids for fluid resuscitation in critically ill people.The Cochrane database of systematic reviews · 2018Pooled it
- Pooled it
- Clinical evidence of inflammation driving secondary brain injury: a systematic review.The journal of trauma and acute care surgery · 2015Pooled it
- Management of bleeding and coagulopathy following major trauma: an updated European guideline.Critical care (London, England) · 2013Pooled it
- [Dealing with massive bleeding and associated perioperative coagulopathy: recommendations for action of the German Society of Anaesthesiology and Intensive Care Medicine].Der Anaesthesist · 2013Guideline
- Effect of Early Versus Delayed Tracheostomy Strategy on Functional Outcome of Patients With Severe Traumatic Brain Injury: A Target Trial Emulation.Critical care explorations · 2024Trial
- Glasgow Outcome Scale Measures and Impact on Analysis and Results of a Randomized Clinical Trial of Severe Traumatic Brain Injury.Journal of neurotrauma · 2019Trial
- Early prediction of outcome after severe traumatic brain injury: a simple and practical model.BMC emergency medicine · 2016Trial
- Revisiting the "Golden Hour": An Evaluation of Out-of-Hospital Time in Shock and Traumatic Brain Injury.Annals of emergency medicine · 2015Trial
- Randomized controlled trial of a scoring aid to improve Glasgow Coma Scale scoring by emergency medical services providers.Annals of emergency medicine · 2015Trial
- Addressing the challenges of obtaining functional outcomes in traumatic brain injury research: missing data patterns, timing of follow-up, and three prognostic models.Journal of neurotrauma · 2014Trial
- Prehospital hypertonic saline resuscitation attenuates the activation and promotes apoptosis of neutrophils in patients with severe traumatic brain injury.Shock (Augusta, Ga.) · 2013Trial
- Transfusion of red blood cells in patients with a prehospital Glasgow Coma Scale score of 8 or less and no evidence of shock is associated with worse outcomes.The journal of trauma and acute care surgery · 2013Trial
- Impact of prehospital mode of transport after severe injury: a multicenter evaluation from the Resuscitation Outcomes Consortium.The journal of trauma and acute care surgery · 2012Trial
- Cellular and Molecular Mechanisms of Hemorrhagic Shock: Biological Rationale for Individualized Fluid Resuscitation Strategies and Multimodal Monitoring.Biomedicines · 2026Review
- Effects of different sodium concentrations in fluids on brain, lung, and kidney in experimental ischemic stroke.Scientific reports · 2025Article
- Recent Advances in Prehospital and In-Hospital Management of Patients with Severe Trauma.Journal of clinical medicine · 2025Review
31 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors at 10 institutions in 2 countries.
Funding
Abstract
contextHypertonic fluids restore cerebral perfusion with reduced cerebral edema and modulate inflammatory response to reduce subsequent neuronal injury and thus have potential benefit in resuscitation of patients with traumatic brain injury (TBI).
objectiveTo determine whether out-of-hospital administration of hypertonic fluids improves neurologic outcome following severe TBI. DESIGN, SETTING, AND
participantsMulticenter, double-blind, randomized, placebo-controlled clinical trial involving 114 North American emergency medical services agencies within the Resuscitation Outcomes Consortium, conducted between May 2006 and May 2009 among patients 15 years or older with blunt trauma and a prehospital Glasgow Coma Scale score of 8 or less who did not meet criteria for hypovolemic shock. Planned enrollment was 2122 patients.
interventionA single 250-mL bolus of 7.5% saline/6% dextran 70 (hypertonic saline/dextran), 7.5% saline (hypertonic saline), or 0.9% saline (normal saline) initiated in the out-of-hospital setting.
main outcome measureSix-month neurologic outcome based on the Extended Glasgow Outcome Scale (GOSE) (dichotomized as >4 or ≤4).
resultsThe study was terminated by the data and safety monitoring board after randomization of 1331 patients, having met prespecified futility criteria. Among the 1282 patients enrolled, 6-month outcomes data were available for 1087 (85%). Baseline characteristics of the groups were equivalent. There was no difference in 6-month neurologic outcome among groups with regard to proportions of patients with severe TBI (GOSE ≤4) (hypertonic saline/dextran vs normal saline: 53.7% vs 51.5%; difference, 2.2% [95% CI, -4.5% to 9.0%]; hypertonic saline vs normal saline: 54.3% vs 51.5%; difference, 2.9% [95% CI, -4.0% to 9.7%]; P = .67). There were no statistically significant differences in distribution of GOSE category or Disability Rating Score by treatment group. Survival at 28 days was 74.3% with hypertonic saline/dextran, 75.7% with hypertonic saline, and 75.1% with normal saline (P = .88).
conclusionAmong patients with severe TBI not in hypovolemic shock, initial resuscitation with either hypertonic saline or hypertonic saline/dextran, compared with normal saline, did not result in superior 6-month neurologic outcome or survival.
trial registrationclinicaltrials.gov Identifier: NCT00316004.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.