Feasibility of Selective Cytopheretic Device (SCD) for Cardiorenal Syndrome Patients Awaiting LVAD
This study is looking at a treatment called the Selective Cytopheretic Device (SCD) for people with acute on chronic systolic congestive heart failure (a severe type of heart failure) and cardiorenal syndrome (problems with both the heart and kidneys). The SCD treatment will be given for 4 hours a day for up to 6 days. We want to see if this treatment can reduce the need for continuous IV vasopressor support (medication to raise blood pressure), prevent heart attacks, and improve survival up to 6 months after treatment. You might be able to join if you are 18 or older, have signs of inflammation (like high CRP or IL-6), are hospitalized for acute decompensated chronic systolic heart failure, and are a potential candidate for an LVAD (Left Ventricular Assist Device). The study plans to enroll 20 participants.
- Study design
- This is an interventional study with a planned enrollment of 20 participants. The study is testing the Selective Cytopheretic Device (SCD).
- What's involved
- You would receive the Selective Cytopheretic Device (SCD) treatment for 4 hours a day for up to 6 consecutive days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your need for vasopressor support will be measured daily. You will be followed for acute myocardial infarction and mortality for up to 6 months after starting SCD treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Need for continuous IV vasopressor supportmeasured daily, at or after 4 hours after termination of daily SCD therapy
Need for continuous IV vasopressor support with \>5 total norepinephrine equivalents and/or \>3 vasopressor agents \>4 hours following termination of daily SCD therapy session to maintain a MAP \>60 mmHg, with norepinephrine equivalents defined as: 1. 1 x epinephrine (ug/kg/min) 2. 001 x dopamine (ug/kg/min) 3. 0.06 x phenylephrine (ug/kg/min) 4. 2.5 x vasopressin (U/min) (Note that use of inotropes (i.e., dobutamine and milrinone) or dopamine at ≤3 mcg/kg/min are not components of this measure.)
- Acute myocardial infarctionup to 6 months following SCD treatment initiation
Acute myocardial infarction as evidenced by elevated cardiac enzymes, with electrocardiographic or imaging findings consistent with myocardial damage and confirmed by Cardiology.
- Mortalityup to 6 months following SCD treatment initiation
Death
- Percentage of subjects with reversal of WRF and increase eGFR and PCWup to 6 days after initiation of SCD therapy
Among patients with WRF, the percentage of subjects with reversal of WRF (≥ 0.5 mg/dL reduction of serum creatinine from level at study entry), and achieving an eGFR \> 30 ml/min/1.73 m2 and PCWP at or below level at study entry at termination of SCD therapy.
- Percentage of subjects who no longer have severe right ventricular failureup to 6 days after initiation of SCD therapy
Among subjects with severe RVF, the percentage of subjects who no longer have severe right ventricular failure, as evidenced by absence of 3 or more of the following 4 indicators of right ventricular failure: 1. CVP \> 16 mmHg 2. CVP/PCWP \> 0.65 3. RVSWI \< 300 mmHg \* mL/m 4. PAPi \< 2
- Adverse Eventsup to 6 days after initiation of SCD therapy
Adverse Events due to SCD, hemodialysis catheter, KRT pump, circuit, and hemofilter