Trial reportAnnals of surgery2011
Out-of-hospital hypertonic resuscitation after traumatic hypovolemic shock: a randomized, placebo controlled trial.
Trial report in Annals of surgery, 2011. 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 106 papers, 11 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 Traumatic Injury With Hypovolemic Shock
Plasma Cytochrome c as Biomarker of Traumatic Injury and Predictor of Outcome
Who cites it
106 citing papers in PubMed, 11 syntheses or guidelines pooled it, 283 citations in OpenAlex.
- Prehospital coagulation management and fluid replacement therapy in patients with multiple and/or severe injuries - A systematic review and clinical practice guideline update.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2025Pooled it
- Efficacy and safety of hypertonic saline solutions fluid resuscitation on hypovolemic shock: A systematic review and meta-analysis of randomized controlled trials.Cardiology journal · 2022Pooled it
- Randomised controlled trials in pre-hospital trauma: a systematic mapping review.Scandinavian journal of trauma, resuscitation and emergency medicine · 2021Pooled it
- 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
- The effectiveness of prehospital hypertonic saline for hypotensive trauma patients: a systematic review and meta-analysis.BMC emergency medicine · 2017Pooled it
- Pooled it
- A Systematic Review of Neuroprotective Strategies during Hypovolemia and Hemorrhagic Shock.International journal of molecular sciences · 2017Pooled it
- Pooled 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
- Trial
- Resuscitative Effect of Centhaquine (LyfaquinAdvances in therapy · 2021Trial
- Plasma-first resuscitation to treat haemorrhagic shock during emergency ground transportation in an urban area: a randomised trial.Lancet (London, England) · 2018Trial
- Goal-directed Hemostatic Resuscitation of Trauma-induced Coagulopathy: A Pragmatic Randomized Clinical Trial Comparing a Viscoelastic Assay to Conventional Coagulation Assays.Annals of surgery · 2016Trial
- Combat: Initial Experience with a Randomized Clinical Trial of Plasma-Based Resuscitation in the Field for Traumatic Hemorrhagic Shock.Shock (Augusta, Ga.) · 2015Trial
- Trial
- Revisiting the "Golden Hour": An Evaluation of Out-of-Hospital Time in Shock and Traumatic Brain Injury.Annals of emergency medicine · 2015Trial
- A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial.The journal of trauma and acute care surgery · 2015Trial
- Effects of terlipressin as early treatment for protection of brain in a model of haemorrhagic shock.Critical care (London, England) · 2015Trial
46 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
16 authors at 8 institutions in 2 countries.
Funding
Abstract
objectiveTo determine whether out-of-hospital administration of hypertonic fluids would improve survival after severe injury with hemorrhagic shock.
backgroundHypertonic fluids have potential benefit in the resuscitation of severely injured patients because of rapid restoration of tissue perfusion, with a smaller volume, and modulation of the inflammatory response, to reduce subsequent organ injury.
methodsMulticenter, randomized, blinded clinical trial, May 2006 to August 2008, 114 emergency medical services agencies in North America within the Resuscitation Outcomes Consortium. INCLUSION CRITERIA: injured patients, age ≥ 15 years with hypovolemic shock (systolic blood pressure ≤ 70 mm Hg or systolic blood pressure 71-90 mm Hg with heart rate ≥ 108 beats per minute). Initial resuscitation fluid, 250 mL of either 7.5% saline per 6% dextran 70 (hypertonic saline/dextran, HSD), 7.5% saline (hypertonic saline, HS), or 0.9% saline (normal saline, NS) administered by out-of-hospital providers. Primary outcome was 28-day survival. On the recommendation of the data and safety monitoring board, the study was stopped early (23% of proposed sample size) for futility and potential safety concern.
results: A total of 853 treated patients were enrolled, among whom 62% were with blunt trauma, 38% with penetrating. There was no difference in 28-day survival-HSD: 74.5% (0.1; 95% confidence interval [CI], -7.5 to 7.8); HS: 73.0% (-1.4; 95% CI, -8.7-6.0); and NS: 74.4%, P = 0.91. There was a higher mortality for the postrandomization subgroup of patients who did not receive blood transfusions in the first 24 hours, who received hypertonic fluids compared to NS [28-day mortality-HSD: 10% (5.2; 95% CI, 0.4-10.1); HS: 12.2% (7.4; 95% CI, 2.5-12.2); and NS: 4.8%, P < 0.01].
conclusionAmong injured patients with hypovolemic shock, initial resuscitation fluid treatment with either HS or HSD compared with NS, did not result in superior 28-day survival. However, interpretation of these findings is limited by the early stopping of the trial. CLINICAL
trial registrationClinical Trials.gov, NCT00316017.
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.