Clinical Trial: Safety Study of a Selective Cytopheric Device (SCD) in Patients With Acute Renal Failure

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Center Pilot Study to Assess the Safety and Efficacy of A Selective Cytopheretic Device (SCD) Treatments In Patients With Acute Renal Failure (ARF)

Brief Summary: The purpose of this protocol is to evaluate the safety of a selective cytopheretic device (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute renal failure (ARF).

Detailed Summary: Acute renal failure is a condition where the kidneys are not capable of producing adequate urine. Therefore, another way to remove waste from the body is needed to hopefully allow time for the kidneys to heal. One method of removing waste from the body is called Continuous Renal Replacement Therapy (CRRT) or variations of that therapy. This study will evaluate the safety of the device while it is connected to the CRRT tubing for up to 7 days. Patients will be followed up until day 60 following the treatment.
Sponsor: CytoPherx, Inc

Current Primary Outcome: To evaluate the safety of the SCD treatment after up to seven consecutive 24 hour SCD treatments compared to historic data on in-hospital mortality and on all cause mortality at day 28, and day 60 following treatment. [ Time Frame: Day 60 following treatment end ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• To assess the effect of SCD treatment on various measures of patient clinical outcomes. [ Time Frame: Day 60 following treatment end ]
  Recording of clinical values such as vital signs, laboratory tests, adverse events, and the need for further dialysis will be tested.
• To evaluate the integrity of the SCD device and patient safety in SCD treatments from the time of initiation of therapy to as many as seven consecutive 24-hour SCD treatments. [ Time Frame: Day 60 following treatment end ]
  This will be done by seeing if the SCD requires changing more often than expected or if there is evidence of clotting.

Original Secondary Outcome: Same as current

Information By: CytoPherx, Inc

Dates:
Date Received: February 17, 2010
Date Started: February 2010
Date Completion:
Last Updated: August 31, 2011
Last Verified: August 2011