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When hyperventilation is recommended as a temporizing measure for the reduction of elevated ICP [ 6 , 18 ], there are fewer reported episodes of hyperventilation therapy or hypothermia. This could also be considered as a beneficial effect of CHT. Given that we have previously reported no rebound of ICH during hyperosmolar therapy tapering [ 10 ], these results suggest that CHT provides prolonged control of ICP after acute brain injury. However, the protective effects observed with the use of CHT can be mediated by other mechanisms than ICP control [ 16 , 19 ].
For example, CHT reduces the risk of hypovolaemia, which is associated with secondary brain injuries [ 20 ]. Before implementing CHT in clinical practice, it is critical to determine the timing of administration that will be the most efficient to enhance outcomes. Continuous hyperosmolar therapy has also been proposed as preventive treatment in brain-injured patients at risk of ICH [ 21 — 23 ].
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Interestingly, our review of the literature provided evidence that CHT reduces the risk of ICH when applied as preventive therapy and we found little difference in the reduction of the risk of death between preventive and curative CHT. Taken altogether, these results suggest that CHT could be used early after TBI in patients deemed at high risk of developing ICH [ 21 , 22 , 24 ] or as a first-step treatment in patients developing ICH, and not only as a rescue therapy in the case of refractory ICH [ 10 ].
One of the main factors hindering the use of CHT is safety. Various neurologic complications including seizure, central pontine myelinolysis, and parenchymal accumulation of osmotic agents have been suspected.
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We did not record any neurological alterations that could be related to CHT, suggesting that it is well-tolerated. However, we are aware that potential clinical side effects could be missed in heavily sedated patients. One of the main fears about the complications of CHT is hypernatraemia, because it has been associated with mortality [ 25 , 26 ]. Hypernatraemia is a common complication after TBI, in up to Moreover, demonstration that poor tolerance of dysnatremia is mainly observed in the case of rapid variations in natraemia [ 29 ] provides a strong rationale to use a continuous infusion adapted to regular biological follow up rather than repeatable boluses of hyperosmolar therapy.
Alteration of renal function has also been reported during CHT [ 30 ]. Our results revealed no changes in urea or creatinine — suggesting no harm to the kidney. However, Froelich et al. Taken together, these data underline the need to set predetermined thresholds for natraemia, enabling a slow and controlled increase in natraemia along with close biological monitoring. This study has several weaknesses. First, this observational cohort demonstrates an association but not a causal link between CHT and survival.
Second, continuous osmotherapy was performed in one centre, exposing our results to a centre effect. Even if we found little heterogeneity in the estimation of the treatment effects between the studies included in the meta-analysis, suggesting that the effect of the treatment is robust to inter-centre variations in clinical practice, we cannot definitively rule out that other interventions participate in the better outcomes of patients treated with CHT.
Notably, moderate hypocapnia and decompressive craniectomy were less frequently used in the group of patients treated than in patients not treated with CHT. Moreover, the blood electrolyte levels were probably more frequently measured in the CHT group than in the control group. However, protocol-based control of natraemia was used in the control group, and no severe dysnatraemia was apparent in this group see Fig. Third, only three randomised trials were available for the review of literature [ 22 , 31 , 32 ].
The results of the systematic review were not significantly changed when only the randomised clinical trials were included. Fourth, the COBI cohort included patients with moderate to severe TBI while other studies covered in the systemic review included patients with severe brain injury. However, the heterogeneity between the subgroups other studies vs. Moreover, the international recommendations on the methodology of clinical trials, which aimed to improve the power of neuro-reanimation trials, argue for the use of inclusion criteria that are as broad as possible, as long as they are compatible with the mechanisms of action of the evaluated intervention [ 34 ].
Since the secondary occurrence of ICH cannot be excluded in patients with moderate head trauma [ 35 ], patients with moderate to severe head trauma were included in this study. Fifth, the rate of pupillary abnormalities was higher in the COBI cohort than in recent studies in patients with moderate to severe TBI [ 36 ]. We therefore cannot exclude that the recorded GCS score underestimates trauma severity and patients with moderate TBI were kept in the analysis. Finally, and despite the very low incidence of side effects recorded in the present results, it should be noted that our study was not powered for a description of side effects.
In conclusion, in this large multicentre cohort study, the use of CHT as a first-tier treatment for ICH was associated with the increased survival of patients with TBI. This association was confirmed in a systematic review including all available clinical studies. The risk of severe hypernatraemia during treatment justifies the setting of thresholds for acceptable hypernatraemia and adapting the flow of hyperosmolar therapy to close biological monitoring.
As advocated by many other authors [ 21 , 24 , 37 ] and international guidelines [ 6 ], a randomised clinical trial appears to be urgently needed to confirm the effects of CHT on the outcomes of patients with TBI. Univariate and multivariate analysis for the risk factors of mortality at day 90 in patients with TBI with intracranial hypertension. Time course of the blood levels of creatinine A and urea B in patients treated or not with continuous hyperosmolar therapy. Flow chart of the literature research for the systematic review of literature.
The study was supported by the university hospital of Nantes, France. The Sponsor and the funders had no role in the design or conduct of the study, the data analysis, the writing of the manuscript or in the decision to submit the manuscript. AR and KA were the principle investigators who oversaw the study. AR helped develop all study materials including the trial protocol, assisted with participant recruitment and data collection at the Nantes site, participated in data analysis and interpretation of the results and drafted and revised the manuscript.
KA provided oversight on trial design, helped develop study materials including the trial protocol, provided oversight on trial conduct, participated in data analysis and the interpretation of the results and revised the manuscript. FF and VS were the trial statisticians and provided advice and input related to all statistical issues, completed final data analysis and interpretation of results and revised the manuscript.
RP was the literature review statistician, and provided advice and input related to all statistical issues, completed final data analysis and interpretation of the results and revised the manuscript. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. All authors read and approved the final manuscript. Informed consent was waived owing to the non-interventional design of this study and because relatives and patients provided informed consent for the collection of medical data in the original studies.
Other authors declare that they have no competing interests. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Catherine Paugam Burtz, Email: Dominique Demeure dit latte, Email: Pierre Joachim Mahe, Email: National Center for Biotechnology Information , U. Journal List Crit Care v.
Published online Dec Author information Article notes Copyright and License information Disclaimer. Received Jul 18; Accepted Dec 5. This article has been cited by other articles in PMC. Associated Data Supplementary Materials Additional file 1: Stages of therapeutic management.
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Continuous hypertonic saline therapy. Supplementary methods for the review of literature. Detailed characteristics of eligible studies. Quality assessment of eligible studies. Results Among the included patients, Electronic supplementary material The online version of this article doi: Background Severe trauma is responsible of more than 5 million deaths every year worldwide and this incidence is expected to increase in the coming decades [ 1 ].
Study design Prospectively collected individual patient data from three studies were pooled together. General care of brain-injured patients stage 1 treatment Investigators followed the brain trauma foundation guidelines for TBI resuscitation [ 6 ], except for one centre, which used CHT as a first-line treatment for ICH. Treatment of intracranial hypertension stage 2 and 3 treatments A bolus of hyperosmolar therapy mannitol 0.
Early continuous hypertonic saline therapy In one of the participating centres, continuous hyperosmolar saline therapy was infused as the first-line treatment of intracranial hypertension i. Data handling For each of the included studies, data were collected prospectively using the specific websites of each trial. Statistical analysis First, in order to identify baseline differences associated with CHT, univariate analysis was applied using the chi-square test for categorical data, Student's t test or Wilcoxon test was used for continuous data and the log-rank test for censored data.
Systematic review Meta-analyses and systematic reviews of observational studies MOOSE guidelines were followed in the design and implementation of this systematic review of the literature. Open in a separate window. Table 1 Comparison of patients with intracranial hypertension treated or not with continuous hyperosmolar therapy CHT. Results express as median 25 th —75 th percentile or number percentage Computed tomography CT classification: Systematic review of the literature Given the potential bias of this observational study, notably a potential centre-effect, the reported increase in the risk of survival associated with CHT could have been underestimated or overestimated.
Additional files Additional file 1: Consent for publication Not applicable. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Footnotes Electronic supplementary material The online version of this article doi: Contributor Information Karim Asehnoune, Phone: For the COBI group: Global burden of diseases, injuries, and risk factors for young people's health during Epidemiology and month outcomes from traumatic brain injury in Australia and New Zealand. Long-term survival of adult trauma patients.
The economic cost of brain disorders in Europe. Trauma mortality in mature trauma systems: An analysis of trauma mortality patterns, Guidelines for the management of severe traumatic brain injury. Equimolar doses of mannitol and hypertonic saline in the treatment of increased intracranial pressure. Sodium lactate versus mannitol in the treatment of intracranial hypertensive episodes in severe traumatic brain-injured patients. Continuous controlled-infusion of hypertonic saline solution in traumatic brain-injured patients:
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