Renal Insufficiency Clinical Trial
The study is intended to verify the safety and assess the performance of up to 3-days treatment protocol with the RenaSense System in ADHF patients.
Status | Not yet recruiting |
Enrollment | 36 |
Est. completion date | |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Females 2. Age 18-85 years 3. Admitted to the hospital with a primary diagnosis of decompensated heart failure 4. Estimated glomerular filtration rate (GFR)* =60 ml/min and =20 ml/min, based on serum creatinine at initial evaluation 5. History of chronic use of oral loop diuretics (= 80 mg/day Furosemide or equivalent) during the past 3 months 6. Indication for treatment with intravenous diuretics 7. Volume overload For patients with a pulmonary artery catheter, persistent volume overload will include: - Pulmonary capillary wedge pressure greater than 22mmHg and one of the following clinical signs: - at least 2+ peripheral edema and/or - Pulmonary edema or pleural effusions on chest x-ray For patients without a pulmonary artery catheter, persistent volume overload will include at least two of the following: - At least 2+ peripheral edema - Jugular venous pressure greater than 10 cm on physical examination (or central venous pressure greater than 10 mmHg when measured) - pulmonary edema or pleural effusions on chest x-ray 8. Indication for urinary catheterization 9. BNP > 400 pg/mL at initial evaluation 10. Able and willing to sign the informed consent Exclusion Criteria: 1. History of urinary tract infection within the last 1 month based on medical history and/or urinalysis on day of admission 2. Gross hematuria, perineal hematoma or symptomatic microscopic hematuria 3. Hypertension, systolic >180 mmHg or diastolic > 110 mmHg 4. Hypotension, systolic pressure <100 mmHg 5. Status post renal denervation 6. Implanted cardiac rhythm management device such as pacemakers, cardiac resynchronization therapy (CRT), Implantable cardioverter-defibrillator (ICD) 7. Suspected or known pregnancy 8. Previous organ transplantation 9. Life threatening condition such as severe infection, malignancy or infarction 10. Subject is participating in other concurrent clinical investigation 11. Diseases or conditions which, in the judgment of the investigator, preclude participation in the clinical trial |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Health Care Campus | Haifa | Outside USA |
Israel | Hillel Yaffe Medical Center | Hedera | |
Israel | Ziv Medical Center | Safed |
Lead Sponsor | Collaborator |
---|---|
Nephera Ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Dosage of Furosemide administration | 72 hours | No | |
Other | Dyspnea score as assessed by Likert scale | 72 hours | No | |
Other | Body weight | 72 hours | No | |
Other | Fractional excretion of Sodium | 24, 48 and 72 hours | No | |
Other | Serum brain natriuretic peptide (BNP) values following 48 and 72 hours of treatment | 48 and 72 hours | No | |
Other | Urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) following 72 hours of treatment as compared to baseline | 72 hours | Yes | |
Primary | Number of Participants with unanticipated adverse events as a measure of safety and tolerability | 72 hours | Yes | |
Secondary | Renal Function as Assessed by Serum Cystatin C level | 24, 48 and 72 hours | No | |
Secondary | Urinary symptoms, hospitalizations and mortality | Assess no increase in urinary symptoms of obstruction or incontinence, hospitalizations and mortality rates following 30 days and 90 days follow-up, as compared to control with no electrical stimulation treatment | 90 days | Yes |
Secondary | Sum of Global Rank Score following 72 hours of treatment as compared to baseline | 72 hours | No | |
Secondary | Urine volume | Urine output volume collected over 24 hour intervals during days 1 to 3 of treatment | 24, 48 and 72 hours | No |
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