CompletedNot Applicable

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

United States35 participantsStarted 2010-02

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. A patient, or legal representative, has signed a written informed consent form.
✓. Must be receiving medical care in an intensive care unit (e.g., ICU, MICU, SICU, CTICU, Trauma, Mixed, other).
✓. Age 18 to 80 years.
✓. Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum.
✓. Must be receiving and tolerating CRRT therapy for a minimum of 4 hours, but not longer than 24 hours.
✓. Expected to remain in the ICU for at least 96 hours after evaluation for enrollment.
✓. A clinical diagnosis of ATN due to hemodynamic or toxic etiologies. ATN is defined as acute renal failure occurring in a setting of acute ischemic or nephrotoxic injury with oliguria (average \<20 mL/hr) for \>6-12 hours or: an increase in serum creatinine ≥2 mg/dL (≥1.5 mg/dL in females) over a period of ≤4 days. (Note: Prerenal, hepatorenal, vascular, interstitial, glomerular, and obstructive etiologies are excluded on clinical or other diagnostic grounds.)
✓. At least one non-renal organ failure (modified SOFA organ system score \>2), as defined in Appendix A or presence (proven or suspected) of sepsis as defined in Appendix B.

Exclusion criteria

✕. Contraindications to regional citrate anticoagulation.
✕. Irreversible brain damage based on available historical and clinical information.
✕. Presence of a renal transplant at any time.
✕. Non-candidacy for acute renal replacement therapy.
✕. Non-renal organ transplantation within six months of screening date.
✕. Presence of preexisting chronic renal failure prior to this episode of ARF. Preexisting chronic renal failure is defined as baseline serum creatinine \>2.5 mg/dL (men), or \>2.0 mg/dL (women).
✕. ARF occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, cyclosporine or tacrolimus nephrotoxicity.
✕. Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after study therapy

What they're measuring

60 Day Mortality

Timeframe: Day 60 following treatment end

60 Day Renal Recovery

Timeframe: Day 60 following treatment end

Trial details

NCT IDNCT01072682

SponsorSeaStar Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-05

Results submitted2022-02-14

View on ClinicalTrials.gov More Acute Renal Failure trials