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. 2013 Jun 25;3:13.
doi: 10.1186/2045-9912-3-13. eCollection 2013.

Safety of Intravenous Administration of Hydrogen-Enriched Fluid in Patients With Acute Cerebral Ischemia: Initial Clinical Studies

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Free PMC article
Case Reports

Safety of Intravenous Administration of Hydrogen-Enriched Fluid in Patients With Acute Cerebral Ischemia: Initial Clinical Studies

Kimihiro Nagatani et al. Med Gas Res. .
Free PMC article

Abstract

Background: Most of the results regarding hydrogen (H2) therapy for acute cerebral ischemia are derived from in vitro studies and animal experiments, with only a few obtained from human trials with a limited number of subjects. Thus, there is a paucity of information regarding both the beneficial therapeutic effects as well as the side effects of H2 on acute cerebral ischemia in humans. We designed a pilot study to investigate single dose intravenous H2-administration in combination with edaravone, aiming to provide an initial estimate of the possible risks and benefits in select patients presenting with acute ischemic stroke.

Methods: An open-label, prospective, non-randomized study of intravenous H2-administration was performed in 38 patients hospitalized for acute ischemic stroke. All patients received an H2-enriched intravenous solution in addition to edaravone immediately after the diagnosis of acute ischemic stroke. Acute stroke patients within 3 h of onset received intravenous tissue plasminogen activator (t-PA) (0.6 mg/kg) treatment, and patients receiving t-PA had to commence the administration of the H2-enriched intravenous solution and edaravone before or at the same time as the t-PA was infused.

Results: Complications were observed in 2 patients (5.3%), which consisted of diarrhea in 1 patient (2.6%) and cardiac failure in 1 patient (2.6%). No deterioration in laboratory tests, urinary tests, ECG, or chest X-ray radiograms occurred in any patient in this study. In all patients, the mean National Institutes of Health Stroke Scale (NIHSS) scores at baseline, and 7, 30, and 90 d after admission were 8.2 ± 7.5, 5.6 ± 7.1, 4.9 ± 6.5, and 4.5 ± 6.3, respectively. The early recanalization was identified in 4 of 11 patients (36.4%) who received intravenous t-PA administration. Hemorrhagic transformation was observed in 2 patients (18.2%). None of the patients in this study that were treated with t-PA developed symptomatic intracranial hemorrhage.

Conclusions: Data from the current study indicate that an H2-enriched intravenous solution is safe for patients with acute cerebral infarction, including patients treated with t-PA.

Keywords: Acute ischemic stroke; Edaravone; Free radical scavenger; Hydrogen; Reactive oxygen species; Safety; Tissue plasminogen activator.

Figures

Figure 1
Figure 1
Changes in the levels of the serum oxidative stress marker MDA-LDL (malondialdehyde-modified LDL). Compared to pretreatment levels, the level of serum MDA-LDL 7 d after admission decreased, but did not differ significantly from that of pretreatment levels in all patients (a) and GI patients (b), respectively (85.4 ± 33.5 vs. 82.6 ±31.5, 86.8 ± 34.7 vs. 86.3 ±33.1). By contrast, in comparison with pretreatment levels, GII patients (c) showed a significant decrease in the MDA-LDL level 7 d after admission (82.1 ± 30.2 vs. 73.2 ± 24.6, *P = 0.0111). Values are expressed as mean ± SD.

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