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

NCT04297345 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-01-03

No results posted yet for this study

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.

Conditions

  • Cerebrovascular Stroke

Interventions

DEVICE

Hemodialysis

Blood enters the extracorporeal circuit from the arterial line of the femoral catheter. For this the investigators use a pump integrated in the monitor, equipped with control systems, exerting a negative pressure. Subsequently, it enters the dialyzer through the internal part of the capillaries (porous), producing a passive exchange of inflammatory and oxidative substances (such as cytokines) with the dialysis fluid, which also circulates through the dialyzer, but through the external part of the capillaries. Blood is returned to the patient, through the venous line of the catheter, with a lower concentration of cytokines after passing through the dialyzer. This circuit is repeated continuously during the 3 hours of the procedure to ensure maximum clearance of glutamate and interleukins, among other substances.

Sponsors & Collaborators

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    lead OTHER

Principal Investigators

  • José Vivancos, MD,PhD · Instituto de Investigación Hospital la Princesa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-11-30
Completion
2022-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04297345 on ClinicalTrials.gov