CompletedNot Applicable

Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis

Germany15 participantsStarted 2016-02

Plain-language summary

The purpose of this study is to determine whether the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is safe in the treatment of dialysis patients with bacteremia.

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. Require renal replacement therapy.
✓. Be ≥ 18 years old and ≤ 90 years old
✓. Positive blood culture and one of the following:
✓. Clinical evidence of a catheter exit site to tunnel infection as evidenced by redness, tenderness or purulence.
✓. Bacteremia is proven with two separate blood cultures from independent vein punctures.
✓. A blood culture with Staphylococcus aureus where the time to positivity is within 14 hours.
✓. Growth from a blood culture taken from the hemodialysis catheter 2 or more hours before the growth of a blood culture drawn peripherally at the same time.

Exclusion criteria

✕. Have an arteriovenous polytetrafluoroethylene (PTFE) graft.
✕. Lack of a commitment to full aggressive support.
✕. Have inability to maintain a minimum mean arterial pressure of ≥ 65 mm Hg despite vasopressor therapy and fluid resuscitation.
✕. Have had chest compressions as part of cardiopulmonary resuscitation (CPR)
✕. Have had an acute myocardial infarction (MI) within the past 3 months.
✕. Have had serious injury within 36 hours of screening.
✕. Have uncontrolled hemorrhage.
✕. Are not expected to live \> 14 days.

What they're measuring

Demonstrate Safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a Hemodialysis Circuit Assessed by Rate of Adverse Events.

Timeframe: 14 days

Trial details

NCT IDNCT02914132

SponsorExThera Medical Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-06-07

Results submitted2019-06-27

View on ClinicalTrials.gov More Bacteremia trials