Hemofiltration in Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      Ischemic stroke is accompanied by a three to four hundred percent increase in the brain's
      extracellular fluid (ECF) and cerebrospinal fluid (CSF) concentration of glutamate, which
      diffuses and damages surrounding neurons. In this study we tested our hypothesis that blood
      glutamate levels can be reduced by hemofiltration, resulting in increased extracellular
      clearance of glutamate and attenuated neurodegeneration, and that decreased blood glutamate
      levels can provide significant neuroprotection against stroke-associated neurodegeneration,
      dysfunction and death. Our primary outcome of interest was to assess safety of hemofiltration
      in acute ischemic stroke patients.
    

Detailed description: 
      Ethical Conduct of the Study

      Investigator Responsibilities

      The principle investigator was responsible for monitoring and responding to adverse events,
      ethical participant use, compliance with the protocols and any protocol amendments, decisions
      to end the study early and compliance with data and sample management protocols. CO-PI was
      trained in both local and international requirements and standards and assisted and report to
      the PI on these tasks.

      Participant Selection and Enrollment

      Eligible participants were identified by medical staff at the ICU or emergency department.
      Enrollment will be standardized and directed by Co-PI.

      Screening for Eligibility

      A screening log was completed for all eligible patients. Data including inclusion criteria
      met, exclusion criteria not met and date consent obtained was collected on this form. It was
      kept in a locked cabinet at the center.

      Informed Consent

      The informed consent form was available in both Russian and Kazakh languages and was approved
      by the Institutional Research Ethics Committee (IREC) before use.

      Monitoring for safety (hemofiltration-related adverse events (HRAE). All adverse events which
      occurred during the course of HF including the serious adverse events (SAE) were documented
      and analyzed. The attending physicians as well as the chief of neurocritical care unit and
      the principal investigator were responsible for screening for HRAE. In case if any of HRAE
      occurred all research team members as well as the chief of ICU and the medical director of
      the hospital were informed. All HRAEs were analyzed by the research team members and the
      medical director of the hospital. The patients were screened for the following adverse
      events: hypotension, hypertension, cardiac dysrhythmia, hypothermia or hyperthermia,
      disorders of water-electrolyte and acid-base balance, bleeding disorders, hemorrhagic
      transformation of acute ischemic stroke.
    

Intervention name(s): Hemofiltration; Standard acute ischemic stroke treatment
Intervention type(s): Device; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Hemofiltration protocol. Hemofiltration was started after all enrollment criteria (informed consent, inclusion/exclusion criteria checklists, registration and assignment to treatment arm) had been met . Vascular access was secured by inserting an 11F double lumen catheter (GamCath, Gambro, Germany) into the jugular, femoral or subclavian vein. CVVH (continuous veno-venous hemofiltration) was carried out using a hemofiltration machine (Fresenius Multifiltrate, Germany). In all patients a 1.9 m2 highly permeable cellulose triacetate hemofilter was used (NIPRO UF205, Nissho corporation, Japan). All patients were treated by CVVH with the predilution mode; the blood flow was set at 180 ml/min.
Masking: None (Open Label)
Primary purpose: Treatment