Health Condition 1: N186- End stage renal disease
Conditions
Sponsors
Bharat Electronics Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patient willing and competent to sign the approved informed consent. Patient must be at least 21 years of age or older. Patient must weigh between 40 and 100kg, inclusive. Patient must have End Stage Renal Disease and currently undergoing consistent intermittent HD at least 2 times a week for at least 3 months prior to being enrolled. Vascular access must be through a functioning arteriovenous fistula (AVF) with no thrombolytic therapy or clotting of the AVF within the past 4 weeks. Willing to comply with the requirements of experimental treatment with the follow-up after 24 hours. Expected survival of no less than 6 months. Consent to allow review of their medical records by the investigators, and monitors. Hemoglobin level = 8.0 g/dL prior to hemodialysis treatment
Exclusion criteria
Exclusion criteria: Anticipating or scheduled for a living related donor kidney transplant in less than 2 months. History (within the 12 weeks prior to the study) of cardiovascular events including. Unstable angina Myocardial Infarction Stroke Clinical Significant Arrhythmia. Life threatening arrhythmia within the past 30 days. Severe intra-dialytic hypotension within the last 30 days. Shock within the last 30 days. Hemodynamic instability as demonstrated by repeated episodes of hypotension or hypertension requiring intervention by dialysis personnel or representing a present hazard to the patient. Seizure disorder requiring active treatment for a seizure episode during the last 6 months. Major Surgery (excluding vascular access surgery) within the past 30 days. Currently receiving intravenous antibiotic therapy for systemic infection. Clinical evidence of metastatic malignancy, receiving radiation or chemotherapy, within the past 365 days. Active bleeding. Hematological disease (e.g. malignancies, hemolytic anemia, thrombocytopenia), and other conditions that may interfere with data. Current enrolment in another investigational device or drug trial. Subject is pregnant (e.g., positive HCG test) or is breast-feeding. Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures. Allergy to heparin or ethylene oxide. Hypertension deemed uncontrolled, at the discretion of the investigator, within the past 30 days. Has an implantable electronic device (e.g. pacemaker). Has no positive viral serology.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety & Efficacy of deviceTimepoint: 4 hours per session | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject vital signs as a Measure of Safety & Tolerability. Number of Participants with Adverse Events as a Measure of Safety & Tolerability. Blood electrolytes as a Measure of Safety & Efficacy. Dialysate toxin load as a Measure of Safety & Tolerability. Satisfaction survey as a Measure of Safety & Tolerability. Blood urea levels. Dialysate Urea Levels. Blood creatinine levels. Dialysate creatinine levels. Volume of spent dialysate. Timepoint: 1 month duration for 04 subjects 50 Sessions each session of 4 Hours | — |
Countries
India
Contacts
Public ContactDr Ravi Prakash Deshpande
KR Hospital Mysore Medical College and Research Institute and Associated hospitals
Outcome results
None listed