Trials / Terminated
TerminatedNCT01400893
Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
A Multi-Center, Randomized, Controlled, Pivotal Study To Assess the Safety and Efficacy of A Selective Cytopheretic Device (SCD) In Patients With Acute Kidney Injury (AKI)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 134 (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 kidney injury (AKI).
Detailed description
Acute kidney injury 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
Interventions
| Type | Name | Description |
|---|---|---|
| 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
- 2011-08-01
- Primary completion
- 2013-09-01
- Completion
- 2013-09-01
- First posted
- 2011-07-25
- Last updated
- 2021-04-27
- Results posted
- 2017-08-29
Locations
26 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01400893. Inclusion in this directory is not an endorsement.