N99.0 N17
Conditions
Interventions
Group 1: Treatment group: single postoperative application of prolonged (4–6 hours) low-intensity ultrasound to both kidneys
Group 2: Control group: no ultrasound application
Sponsors
Renal Innovation Ltd.
Eligibility
Sex/Gender
All
Age
30 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patient that is expected to undergo an elective cardiac surgery within 1-14 days after enrollment with cardio-pulmonary bypass machine on non-beating heart (including aortic valve surgery, mitral valve surgery, coronary artery bypass grafting, or combination of these procedures) 2. Patient that already has a Foley catheter or agrees to have one during the study for 72 hours post-operation 3. Patient agrees to have an IV port for drawing blood samples 4. History of chronic kidney disease stage III, as indicated by 30<eGFR<60 ml/min/1.73m2(as calculated by chronic kidney disease Epidemiology Collaboration (CKD-EPI) formula), and 1.2<serum creatinine level=2.5 mg/dL from medical records within 30 days prior to the surgery 5. Cleveland Clinic Dialysis After Cardiac Surgery Risk Score = 5 and =8 6. Patient is capable of meeting study requirements including followup assessment 7. Patient that is willing to comply with being connected to the ultrasound device for 6 hours 8. Investigator believes that the patient is able to tolerate using or being connected to the device for over 6 hours 9. Patient has been informed on the nature of the study, agrees to participate, and signed the informed consent document
Exclusion criteria
Exclusion criteria: Prior to surgery: 1. Patient undergoing an emergency surgery, or patient experiencing fast deterioration in the hospital to a condition that requires urgent cardio-surgery, or an aortic-arch replacement, or a re-do operation within 3 months, or had other cardio surgery within 3 months 2. Patient with (or undergoing a procedure for) VAD or heart transplant 3. Documented, or observed in ultrasound by an ultrasound specialist, abnormal kidney anatomy, abnormal location, abnormal orientation, kidney stones, kidney tumor or significant cysts polycystic kidney, one kidney only, transplanted kidney, or fatty liver disease 4. Patient whose kidneys are not clearly visualized using the test ultrasound device (due to e.g., fatty liver, high BMI, etc), or with documented BMI>35 Kg/m2 5. Ejection fraction of 0.4 microgr/Kg/min norepinephrine, and exclude positive inotropes (e.g. dobutamine). 25. Patient that immediately post-surgery requires circulatory support (e.g. ECMO, VAD, pump, Impella, etc.) or dialysis 26. Hemodynamic instability as determined by the investigator to be unsuitable for participation in the study (e.g. Sys BP <90 mmHg for more than 15 min after the surgery) 27. Ventricular arrhythmia that was developed after the surgery which requires substantial continuous pacing 28. Active bleeding within 1 hours after surgery 29. Observed (by the operator using the ultrasound system) abnormal kidney anatomy, abnormal location, abnormal orientation, kidney stones, kidney tumor, one kidney only, or transplante
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the use of prolonged low-intensity ultrasound energy applied to the kidneys. Safety will be evaluated until the earlier of hospital discharge or 5 days from surgery. The safety endpoint will include the incidence and severity of: - Unanticipated ultrasound application related adverse events. - Serious Adverse Events related to the ultrasound application. Safety assessment will be based upon monitored Adverse Events. All adverse events and serious adverse events will be reported in accordance with the reviewing Ethics Committee, Competent authority requirements, and the study protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| The need for dialysis or Renal Replacement Therapy (RRT): time to first RRT event, number of RRT sessions, and overall duration of RRT during the 5-day follow-up period while in hospital. | — |
Countries
Germany
Contacts
Public ContactMichael A. Borger
Herzzentrum Leipzig
Outcome results
None listed