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Assessment of two prophylactic fluid strategies in aneurysmal subarachnoid hemorrhage: A randomized trial.

ABSTRACT: OBJECTIVE:To compare the effect of two prophylactic euvolemic fluid strategy regimens on the incidence of cerebral vasospasm and clinical outcomes in patients with aneurysmal subarachnoid hemorrhage (SAH). METHODS:Ninety-six patients with a basal intravenous intake of 15 mL/kg/day of Ringer's lactate solution were included, and an additional 15 to 50 mL/kg/day Ringer's lactate (RL-group) or hydroxyethyl starch 130/0.4 solution (HES-group) was administered to maintain the targeted mean arterial pressure. The primary end point was the occurrence of cerebral vasospasm during the first 14 days. The secondary end points were case fatality, Barthel's index, and Glasgow Outcome Scores (GOS) at 30 days after SAH. RESULTS:Cerebral vasospasm developed in 42 patients (43.7%), and nine of these events were severe. The vasospasm rate among the RL- and HES-based groups was 25/48 and 17/48, respectively. For the secondary endpoint, four patients (4%) died by the end of follow-up (two in each group). Unfavorable outcome cases were not different in the RL and HES groups (9 vs. 14, respectively). There was no difference between the Barthel's scores at 30 days between the two groups. CONCLUSIONS:Using starches in a prophylactic treatment strategy in aneurysmal SAH in not supported by the study.The trial was registered at Clinicaltrials.gov under the number NCT02064075.

SUBMITTER: Gal J

PROVIDER: S-EPMC7375726 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Assessment of two prophylactic fluid strategies in aneurysmal subarachnoid hemorrhage: A randomized trial.

Gál Judit J Fülesdi Béla B Varga Dávid D Fodor Babett B Varga Eszter E Siró Péter P Bereczki Dániel D Szabó Sándor S Molnár Csilla C

The Journal of international medical research 20200701 7

<h4>Objective</h4>To compare the effect of two prophylactic euvolemic fluid strategy regimens on the incidence of cerebral vasospasm and clinical outcomes in patients with aneurysmal subarachnoid hemorrhage (SAH).<h4>Methods</h4>Ninety-six patients with a basal intravenous intake of 15 mL/kg/day of Ringer's lactate solution were included, and an additional 15 to 50 mL/kg/day Ringer's lactate (RL-group) or hydroxyethyl starch 130/0.4 solution (HES-group) was administered to maintain the targeted ...[more]

PMID: 32689849

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Project description:ImportanceAfter aneurysmal subarachnoid hemorrhage, the use of lumbar drains has been suggested to decrease the incidence of delayed cerebral ischemia and improve long-term outcome.ObjectiveTo determine the effectiveness of early lumbar cerebrospinal fluid drainage added to standard of care in patients after aneurysmal subarachnoid hemorrhage.Design, setting, and participantsThe EARLYDRAIN trial was a pragmatic, multicenter, parallel-group, open-label randomized clinical trial with blinded end point evaluation conducted at 19 centers in Germany, Switzerland, and Canada. The first patient entered January 31, 2011, and the last on January 24, 2016, after 307 randomizations. Follow-up was completed July 2016. Query and retrieval of data on missing items in the case report forms was completed in September 2020. A total of 20 randomizations were invalid, the main reason being lack of informed consent. No participants meeting all inclusion and exclusion criteria were excluded from the intention-to-treat analysis. Exclusion of patients was only performed in per-protocol sensitivity analysis. A total of 287 adult patients with acute aneurysmal subarachnoid hemorrhage of all clinical grades were analyzable. Aneurysm treatment with clipping or coiling was performed within 48 hours.InterventionA total of 144 patients were randomized to receive an additional lumbar drain after aneurysm treatment and 143 patients to standard of care only. Early lumbar drainage with 5 mL per hour was started within 72 hours of the subarachnoid hemorrhage.Main outcomes and measuresPrimary outcome was the rate of unfavorable outcome, defined as modified Rankin Scale score of 3 to 6 (range, 0 to 6), obtained by masked assessors 6 months after hemorrhage.ResultsOf 287 included patients, 197 (68.6%) were female, and the median (IQR) age was 55 (48-63) years. Lumbar drainage started at a median (IQR) of day 2 (1-2) after aneurysmal subarachnoid hemorrhage. At 6 months, 47 patients (32.6%) in the lumbar drain group and 64 patients (44.8%) in the standard of care group had an unfavorable neurological outcome (risk ratio, 0.73; 95% CI, 0.52 to 0.98; absolute risk difference, -0.12; 95% CI, -0.23 to -0.01; P = .04). Patients treated with a lumbar drain had fewer secondary infarctions at discharge (41 patients [28.5%] vs 57 patients [39.9%]; risk ratio, 0.71; 95% CI, 0.49 to 0.99; absolute risk difference, -0.11; 95% CI, -0.22 to 0; P = .04).Conclusion and relevanceIn this trial, prophylactic lumbar drainage after aneurysmal subarachnoid hemorrhage lessened the burden of secondary infarction and decreased the rate of unfavorable outcome at 6 months. These findings support the use of lumbar drains after aneurysmal subarachnoid hemorrhage.Trial registrationClinicalTrials.gov Identifier: NCT01258257.

Project description:Object: The aim of this study was to investigate metabolite levels in cerebrospinal fluid (CSF) in their time-dependent course after aneurysmal subarachnoid hemorrhage (aSAH) comparing them to patients harboring unruptured intracranial aneurysms. Methods: Eighty CSF samples of 16 patients were analyzed. The study population included patients undergoing endovascular/microsurgical treatment of ruptured intracranial aneurysms (n = 8), which were assessed for 9 days after aSAH. Control samples were collected from the basal cisterns in elective aneurysm surgery (n = 8). The CSF samples were consecutively collected with extraventricular drain (EVD) placement/intraoperatively, 6 h later, and daily thereafter (day 1-9). The endogenous metabolites were analyzed with a targeted quantitative and quality controlled metabolomics approach using the AbsoluteIDQ®p180Kit. Differences inbetween timepoints and compared to the control group were evaluated. Results: Numerous alterations of amino acid (AA) levels were detected within the first hours after bleeding. The highest mean concentrations occurred 1 week after aSAH. AA levels were continuously increasing over time starting 6 h after aSAH. Taurine concentration was highest briefly after aSAH starting to decrease already after 6 h (vs. day 1-9, p = 0.02). The levels of sphingomyelins/ phosphatidylcholines/ lysophosphatidylcholines/mono-unsaturated fatty acid chain were highly elevated on day 0 (compared to other timepoints or controls, p < 0.01) and decreased over the next several days to concentrations comparable to the control group. Carnitine concentrations were decreased after SAH (vs. day 7, p < 0.01), while they recovered within the next day. The Fischer ratio of branched-chain AA to aromatic AA was lowest immediately after SAH and increased in 7 days (p < 0.001). Conclusion: AA levels in CSF increased overtime and often differ from patients without SAH. There was a peak concentration of structural AA within the first 6 h after aneurysm treatment. Time-dependent alterations of CSF metabolites and compounds may elucidate pathophysiological processes after aSAH, providing potential predictors assessed non-invasively by routine lab testing.

Project description:BackgroundThe options of surgical approach and treatment stage are two challenging treatment strategy issues with multiple intracranial aneurysmal subarachnoid hemorrhage (MIA-SAH).MethodsWe retrospectively analyzed data from patients with MIA-SAH who underwent surgery in our center between January 1, 2014 and September 1, 2022. To define "zone classification", the cranial cavity was divided into four zones by the planes of cerebral falx and tentorium cerebelli. Aneurysms isolated to one zone were defined as zone classification I; those crossing two zones were defined as zone classification II; those crossing three zones were defined as zone classification III; and those crossing four zones were defined as zone classification IV. General and aneurysmal-related characteristics of patients with different zone classifications were collected and compared between two surgical approaches. Multivariate logistic regression analysis was used to identify factors independently associated with multistage treatment options.ResultsA total of 226 patients with 523 aneurysms were included. The proportion of patients undergoing endovascular treatment increased with higher zone classification (I: 85.4%; II: 94.0%; III: 100.0%; IV: 100.0%). The proportion of patients receiving one-stage treatment decreased with higher zone classification (I: 60.2%; II: 33.6%; III: 0.0%; IV: 0.0%). Compared with patients undergoing microsurgical clipping, more patients undergoing endovascular treatment had zone classification II-IV (56.9% vs. 31.8%, p = 0.025). Zone classification II-IV (odds ratio [OR] = 3.821, 95% confidence interval [CI]: 2.041-7.154, p < 0.001), endovascular treatment (OR = 8.756, 95% CI: 2.589-29.609, p < 0.001), and size of all unruptured aneurysms <3 mm (OR = 4.531, 95% CI: 2.315-8.871, p < 0.001) were each independently associated with multistage treatment.ConclusionsZone classification provides a new idea in MIA-SAH treatment strategies, especially regarding surgical approach and treatment stage options.

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Assessment of two prophylactic fluid strategies in aneurysmal subarachnoid hemorrhage: A randomized trial.

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Assessment of two prophylactic fluid strategies in aneurysmal subarachnoid hemorrhage: A randomized trial.

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