Clinical Trial: A Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multi-Center, Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI)

Brief Summary: The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute kidney injury (AKI). Funding Source - FDA OOPD (SCD-PED-01)

Detailed Summary: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to commercially available Continuous Renal Replacement Therapy (CRRT) devices. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and it is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
Sponsor: CytoPherx, Inc

Current Primary Outcome: Primary Objective: Adverse events related to treatment occurring during and 60 days post treatment initiation. [ Time Frame: 60 days ]

The primary clinical endpoint in this trial is safety of SCD treatment after up to seven consecutive 24 hour therapy sessions. Safety as determined with adverse events related to treatment up to 60 days following treatment initiation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The effect of SCD treatment on all cause mortality through 60 days post-randomization. [ Time Frame: Day 60 following treatment end ]
    The effect of SCD treatment on all cause mortality through 60 days post-randomization.
  • The effect of SCD treatment on Renal Replacement Therapy dependency at day 60. [ Time Frame: Day 60 following treatment end ]
    RRT dependency at day 60 is defined as patient not receiving any form of intermittent or continuous renal replacement therapy at 60 days post enrollment in the study with no plans for additional intermittent or continuous renal replacement therapy.
  • Mortality at day 28 [ Time Frame: Day 28 following treatment ]
    Mortality at day 28 following treatment


Original Secondary Outcome: Same as current

Information By: CytoPherx, Inc

Dates:
Date Received: June 7, 2016
Date Started: October 2016
Date Completion:
Last Updated: April 19, 2017
Last Verified: April 2017