Feasibility and Safety Study to Evaluate the Neuroprotective Effect of Hemodialysis in Acute Ischemic Stroke — DIAGLUICTUS2  

Cerebrovascular Stroke Clinical Trial

Official title: Feasibility, Safety, Randomized, Controlled, Open-label Study to Evaluate the Neuroprotective Effect of Hemodialysis of Plasma Glutamate and Proinflammatory Cytokines in the Acute Phase of Ischemic Stroke

Status Recruiting

Clinical Trial Summary

Hemodialysis is a therapeutic strategy used in subjects with chronic renal failure. Our working hypothesis is based on results published in experimental animal models of stroke where the investigators have demonstrated that peritoneal dialysis is an effective technique to reduce blood glutamate levels and reduce infarct volume.

The objective of this clinical trial is to evaluate the viability, safety and efficacy of hemodialysis in patients with acute ischemic stroke, proposing that it may have a) a potential neuroprotective effect by reducing the excitotoxic levels of glutamate and proinflammatory cytokines in blood and b) fewer technical problems than peritoneal dialysis to apply in usual clinical practice.

Clinical Trial Description

The reason for the present study is based on previous data from the group that demonstrated the following results: a) The decrease in plasma Glu, by peritoneal dialysis (PD), reduces the size of the brain infarct in a model of focal cerebral ischemia in rats; b) PD is effective in reducing plasma Glu levels in patients with chronic renal failure; c) PD is a safe and well tolerated procedure in patients with ischemic stroke in the acute phase, however, it was not a viable procedure in our conditions, due to the malfunction of the automatic system that made it difficult for the inclusion sessions and dialysate extraction and the difficulty for the collaboration of this type of patient with the procedure; d). The increase in the median concentration of Glu after cerebral infarction was reduced to 46% after PD.

Based on our previous results, the investigators believe that hemodialysis may have fewer technical problems than PD and serve as a neuroprotection technique by lowering the levels of Glu and proinflammatory cytokines in blood. To do this, the investigators establish the following objectives: a) To evaluate the feasibility and safety of a hemodialysis procedure in patients with acute ischemic stroke compared to a control group; b) To analyze the clinical benefit of hemodialysis estimated by the volume of the infarction and the neurological and functional situation of the patients; and c) To measure the levels of glutamate and proinflammatory cytokines in plasma and dialysate samples. For this, a single-center, randomized, open-label, controlled study has been designed with a group of patients with ischemic stroke who receive conventional treatment (N=10) or conventional treatment + 2 hemodialysis sessions (N=10) in the acute phase of the stroke (Phase IIa clinical trial with medical device). ;

Related Conditions & MeSH terms

• Cerebrovascular Stroke
• Ischemic Stroke
• Stroke

• NCT number: NCT04297345
• Study type: Interventional
• Source: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Contact: Monica Sobrado, PhD
• Phone: +34915202416
• Email: sobrado.m@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Completion date: December 2022