Hydrogen IV Plus Magnesium May Help Severe Brain Hemorrhage Patients

Authors
Journal
BMC Neurology
Year
DOI
10.1186/s12883-014-0176-1
Study Type
clinical
Peer Reviewed
Yes
Country
Japan
Health Condition
Subarachnoid Hemorrhage
Body System
Nervous System

TL;DR

Researchers are testing whether two new treatments—hydrogen-rich fluid and magnesium sulfate—can help protect the brains of people who have severe bleeding in their brain. They want to see if this combination stops complications that damage the brain after the initial bleeding and improves how well patients recover.

Key Finding

This is a study protocol describing a planned clinical trial, not a completed study with results; no findings are available yet.

Summary

This is a study protocol (a plan for a future study) describing a clinical trial that will test whether hydrogen-rich fluid given intravenously, combined with magnesium sulfate delivered directly to the brain, can help patients who have suffered a severe type of brain bleed called subarachnoid hemorrhage. The trial will enroll 450 patients and compare three groups: one receiving both hydrogen and magnesium, one receiving only magnesium, and a control group, to see if the combination therapy reduces complications like delayed brain damage and improves patient recovery.

Practical Takeaway

This protocol outlines a future trial investigating hydrogen therapy for a serious medical emergency (severe brain hemorrhage). Since the study has not yet been completed and results are not available, there are no practical takeaways about hydrogen's effectiveness for consumers at this time. Results from this trial, once published, may provide evidence relevant to hydrogen therapy in critical care settings.

Abstract

Background The failures of recent studies intended to prevent cerebral vasospasm have moved the focus of research into delayed cerebral ischemia away from cerebral artery constriction towards other mechanisms. Recent accumulating evidence has suggested that early brain injury is also involved in the development of delayed cerebral ischemia, and that hydrogen can prevent early brain injury. Therefore, we have established a combination therapy of intravenous hydrogen infusion and intra-cisternal magnesium sulfate infusion for the treatment of both early brain injury and cerebral vasospasm. The present randomized controlled clinical trial is designed to investigate the effects of this novel therapeutic strategy on the occurrence of cerebral vasospasm, delayed cerebral ischemia, and clinical outcomes after high-grade subarachnoid hemorrhage.Methods This study is a randomized, double-blind, placebo-controlled design to be conducted in two hospitals. A total of 450 patients with high-grade subarachnoid hemorrhage will be randomized to one of three arms: (i) Mg¿+¿H2 group, (ii) Mg group, and (iii) control group. Patients who are assigned to the Mg¿+¿H2 group will receive intra-cisternal magnesium sulfate infusion (2.5 mmol/L) at 20 mL/h for 14 days and intravenous hydrogen-rich fluid infusion (200 mL) twice a day for 14 days. Patients who are assigned to the Mg group will receive intra-cisternal magnesium sulfate infusion (2.5 mmol/L) at 20 mL/h for 14 days and intravenous normal glucose-electrolyte solution (200 mL) without added hydrogen twice a day for 14 days. Patients who are assigned to the control group will receive intra-cisternal Ringer solution without magnesium sulfate at 20 mL/h for 14 days and intravenous normal glucose-electrolyte solution (200 mL) without added hydrogen twice a day for 14 days. Primary outcome measures will be occurrence of delayed cerebral ischemia and cerebral vasospasm. Secondary outcome measures will be modified Rankin scale score at 3, 6, and 12 months and biochemical markers.DiscussionThe present protocol for a randomized, placebo-controlled study of intravenous hydrogen therapy with intra-cisternal magnesium infusion is expected to establish the efficacy and safety of this therapeutic strategy.Trial registrationUMIN-CTR: UMIN000014696.