Acute Kidney Injury
Conditions
Keywords
Acute Renal Failure, Acute kidney injury, Continuous Renal Replacement Therapy, Selective cytopheretic device, Pediatric
Brief summary
The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute kidney injury (AKI). Funding Source - FDA OOPD (SCD-PED-01)
Detailed description
The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to commercially available Continuous Renal Replacement Therapy (CRRT) devices. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and it is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
Interventions
DEVICESCD-F40
CRRT with SCD
Sponsors
Innovative BioTherapies (IBT)
Children's Hospital Medical Center, Cincinnati
CytoPherx, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 22 Years
Healthy volunteers
No
Inclusion criteria
1. A patient, or legal representative, has signed a written informed consent form. 2. Must be receiving medical care in an intensive care unit (e.g., ICU, MICU, SICU, CTICU, Trauma). 3. Age less than 22 years. 4. Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum. 5. Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours. 6. Clinical diagnosis of AKI due to etiologies requiring CRRT (see Appendix B). AKI is defined as acute kidney injury with any one of the following: * Increase in SCr by ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours or; * Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days or; * Urine volume \<0.5ml/kg/h for 6 hours 7. At least one non-renal organ failure (defined as receiving mechanical ventilation or at least one vasoactive medication to treat hypotension) OR presence (proven or suspected) of sepsis. (Appendix C).
Exclusion criteria
1. Irreversible brain damage based on available historical and clinical information. 2. Presence of any organ transplant at any time. 3. Acute or chronic use of circulatory support device such as LVADs, RVADs, BIVADs, ECMO(a). 4. Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring CRRT prior to this episode of AKI. 5. AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome(b), thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, cyclosporine, or tacrolimus nephrotoxicity 6. Received \>12hrs of CRRT during this hospital admission or prior to transfer from an outside hospital. 7. Received \>1 hemodialysis treatment during this hospital admission or prior to transfer from an outside hospital. 8. Hospitalization \>14 days during this hospital admission and or prior to transfer from an outside hospital. 9. Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three-month period after study therapy. 10. Chronic immunosuppression. 11. HIV or AIDS. 12. Severe liver failure(c). 13. Current Do Not Attempt Resuscitation (DNAR), Allow Natural Death (AND), or withdrawal of care status, or anticipated change in status within the next 7 days. 14. Patient is moribund or chronically debilitated for whom full supportive care is not indicated. 15. Patient not expected to survive 28 days because of an irreversible medical condition. (This is not restrictive to AKI, and may include situations such as the presence of irreversible brain damage, untreatable malignancy, inoperable life threatening condition, or any condition to which therapy is regarded as futile by the PI.) 16. Any medical condition that the Investigator thinks may interfere with the study objectives. 17. Physician refusal. 18. Dry weight of \<20kg(d). 19. Platelet count \<30,000/mm3 at time of screening(e). 20. Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical trials where only measurements and/or samples are taken (NO TEST DEVICE OR TEST DRUG USED) are allowed to participate. 21. Use of any other Investigational drug or device within the previous 30 days. 1. ECMO was subsequently removed as an exclusion. Two patients in the study received ECMO. 2. Hemolytic uremic syndrome subsequently removed as an exclusion. One patient in the study had HUS. 3. Severe liver failure was change to severe chronic liver failure during the study course. 4. The lower weight limit threshold was decreased to 15 kg after consultation and approval from the US FDA. 5. The thrombocytopenia exclusion removed after no observed occurrences in the first five subjects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 60 days post treatment initiation | Adverse events related to device treatment occurring during and 60 days post treatment initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Mortality Through 60 Days Post-randomization. | Day 60 | The effect of SCD treatment on all cause mortality through 60 days post-randomization. |
| Mortality at Day 28 | Day 28 following treatment | Mortality at day 28 following treatment |
| The Effect of SCD Treatment on Renal Replacement Therapy Dependency at Day 60. | 60 days | RRT dependency at day 60 is defined as patient not receiving any form of intermittent or continuous renal replacement therapy at 60 days post enrollment in the study with no plans for additional intermittent or continuous renal replacement therapy. |
Countries
United States
Participant flow
Recruitment details
A total of 19 subjects have been consented for this trial. 16 of the nineteen went on to receive the SCD device.
Participants by arm
| Arm | Count |
|---|---|
| CRRT + SCD The Selective Cytopheretic Device (SCD) is comprised of tubing, connectors, and a synthetic membrane cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and it is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | CRRT + SCD |
|---|---|
| Age, Continuous | 12.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 16 |
| other Total, other adverse events | 14 / 16 |
| serious Total, serious adverse events | 8 / 16 |
Outcome results
Primary
Adverse Events
Adverse events related to device treatment occurring during and 60 days post treatment initiation
Time frame: 60 days post treatment initiation
Population: Adverse events related to SCD treatment up to 60 days following treatment initiation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Adverse Events | 0 adverse event |
Secondary
All Cause Mortality Through 60 Days Post-randomization.
The effect of SCD treatment on all cause mortality through 60 days post-randomization.
Time frame: Day 60
Population: Outcome data is reported for those subjects in which the calcium levels were maintained in the protocol's recommended range (≤0.4 mmol/L) for greater or equal to 90% of the therapy time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment | All Cause Mortality Through 60 Days Post-randomization. | Survival | 12 Participants |
| Treatment | All Cause Mortality Through 60 Days Post-randomization. | Non-survival | 4 Participants |
Secondary
Mortality at Day 28
Mortality at day 28 following treatment
Time frame: Day 28 following treatment
Population: Outcome data is reported for those subjects in which the calcium levels were maintained in the protocol's recommended range (≤0.4 mmol/L) for greater or equal to 90% of the therapy time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment | Mortality at Day 28 | Non survival | 0 Participants |
| Treatment | Mortality at Day 28 | Survival | 16 Participants |
Secondary
The Effect of SCD Treatment on Renal Replacement Therapy Dependency at Day 60.
RRT dependency at day 60 is defined as patient not receiving any form of intermittent or continuous renal replacement therapy at 60 days post enrollment in the study with no plans for additional intermittent or continuous renal replacement therapy.
Time frame: 60 days
Population: Survivors at day 60
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment | The Effect of SCD Treatment on Renal Replacement Therapy Dependency at Day 60. | No dialysis dependency | 12 Participants |
| Treatment | The Effect of SCD Treatment on Renal Replacement Therapy Dependency at Day 60. | Dialysis dependency | 0 Participants |