NCT01072682

Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: SeaStar Medical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Acute Renal Failure

Interventions

Type	Name	Description
DEVICE	Selective cytopheretic device (SCD)	The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. 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 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.

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-02-22
• Last updated: 2022-03-31
• Results posted: 2022-03-09

Locations

7 sites across 1 country: United States