| Title: |
Effect of Continuous Infusion of Hypertonic Saline vs Standard Care on 6-Month Neurological Outcomes in Patients With Traumatic Brain Injury |
| Authors: |
Roquilly, Antoine; Moyer, Jean Denis; Huet, Olivier; Lasocki, Sigismond; Cohen, Benjamin; Dahyot-Fizelier, Claire; Chalard, Kevin; Seguin, Philippe; Jeantrelle, Caroline; Vermeersch, Véronique; Gaillard, Thomas; Cinotti, Raphael; Demeure Dit Latte, Dominique; Mahe, Pierre Joachim; Vourc’h, Mickael; Martin, Florian Pierre; Chopin, Alice; Lerebourg, Céline; Flet, Laurent; Chiffoleau, Anne; Feuillet, Fanny; Asehnoune, Karim |
| Contributors: |
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes); Hôpital Beaujon AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); CHRU Brest - Département d'Anesthésie Réanimation (CHU - BREST - DAR); Centre Hospitalier Régional Universitaire de Brest (CHRU Brest); Optimisation des régulations physiologiques (ORPHY (EA 4324)); Université de Brest (UBO EPE)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)-Institut Brestois Santé Agro Matière (IBSAM); Université de Brest (UBO EPE)-Université de Brest (UBO EPE); Centre Hospitalier Universitaire d'Angers (CHU Angers); Centre Hospitalier Régional Universitaire de Tours (CHRU Tours); Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie ); Pharmacologie des anti-infectieux U 1070 (PHAR Poitiers ); Université de Poitiers = University of Poitiers (UP)-Institut National de la Santé et de la Recherche Médicale (INSERM); Université de Poitiers – UFR Santé Faculté de Médecine et de Pharmacie (UFR Santé Poitiers ); Université de Poitiers = University of Poitiers (UP); CHU Montpellier = Montpellier University Hospital; Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier); Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou; methodS in Patients-centered outcomes and HEalth ResEarch (SPHERE); Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques (UFR SPB); Université de Nantes (UN)-Université de Nantes (UN); Atlanrea Study Group and the Société Française d’Anesthésie Réanimation (SFAR) Research Network: Hélène Beloeil, Yoann Launey, Audrey Tawa, Rémy Bellier, Thierry Bénard, Soizic Gergaud, Maxime Léger, Pierre-Francois Perrigault, Camille Hego, Mathilde Holleville, Hourmant Yannick, Bouras Marwan, Remérand Francis, Bourdiol Alexandre, Carole Ichai, Nino Stocchetti, Nicolas Molinari |
| Source: |
ISSN: 2380-6583. |
| Publisher Information: |
CCSD; American Medical Association |
| Publication Year: |
2021 |
| Collection: |
Université de Poitiers: Publications de nos chercheurs.ses (HAL) |
| Subject Terms: |
[SDV]Life Sciences [q-bio]; [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences |
| Description: |
International audience ; Importance: Fluid therapy is an important component of care for patients with traumatic brain injury, but whether it modulates clinical outcomes remains unclear.Objective: To determine whether continuous infusion of hypertonic saline solution improves neurological outcome at 6 months in patients with traumatic brain injury.Design, setting, and participants: Multicenter randomized clinical trial conducted in 9 intensive care units in France, including 370 patients with moderate to severe traumatic brain injury who were recruited from October 2017 to August 2019. Follow-up was completed in February 2020.Interventions: Adult patients with moderate to severe traumatic brain injury were randomly assigned to receive continuous infusion of 20% hypertonic saline solution plus standard care (n = 185) or standard care alone (controls; n = 185). The 20% hypertonic saline solution was administered for 48 hours or longer if patients remained at risk of intracranial hypertension.Main outcomes and measures: The primary outcome was Extended Glasgow Outcome Scale (GOS-E) score (range, 1-8, with lower scores indicating worse functional outcome) at 6 months, obtained centrally by blinded assessors and analyzed with ordinal logistic regression adjusted for prespecified prognostic factors (with a common odds ratio [OR] >1.0 favoring intervention). There were 12 secondary outcomes measured at multiple time points, including development of intracranial hypertension and 6-month mortality.Results: Among 370 patients who were randomized (median age, 44 [interquartile range, 27-59] years; 77 [20.2%] women), 359 (97%) completed the trial. The adjusted common OR for the GOS-E score at 6 months was 1.02 (95% CI, 0.71-1.47; P = .92). Of the 12 secondary outcomes, 10 were not significantly different. Intracranial hypertension developed in 62 (33.7%) patients in the intervention group and 66 (36.3%) patients in the control group (absolute difference, -2.6% [95% CI, -12.3% to 7.2%]; OR, 0.80 [95% CI, 0.51-1.26]). ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/34032829; PUBMED: 34032829; PUBMEDCENTRAL: PMC8150692 |
| DOI: |
10.1001/jama.2021.5561 |
| Availability: |
https://hal.science/hal-03623709; https://doi.org/10.1001/jama.2021.5561 |
| Accession Number: |
edsbas.1C3533F6 |
| Database: |
BASE |