Trial Outcomes & Findings for Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI). (NCT NCT02820350)
NCT ID: NCT02820350
Last Updated: 2024-06-20
Results Overview
Adverse events related to device treatment occurring during and 60 days post treatment initiation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
60 days post treatment initiation
Results posted on
2024-06-20
Participant Flow
A total of 19 subjects have been consented for this trial. 16 of the nineteen went on to receive the SCD device.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Death
|
4
|
Baseline Characteristics
Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).
Baseline characteristics by cohort
| Measure |
CRRT + SCD
n=16 Participants
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.
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|---|---|
|
Age, Continuous
|
12.3 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 60 days post treatment initiationPopulation: Adverse events related to SCD treatment up to 60 days following treatment initiation
Adverse events related to device treatment occurring during and 60 days post treatment initiation
Outcome measures
| Measure |
Treatment
n=16 Participants
Treatment arm only
SCD-F40: CRRT with SCD
|
|---|---|
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Adverse Events
|
0 adverse event
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SECONDARY outcome
Timeframe: Day 60Population: 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.
The effect of SCD treatment on all cause mortality through 60 days post-randomization.
Outcome measures
| Measure |
Treatment
n=16 Participants
Treatment arm only
SCD-F40: CRRT with SCD
|
|---|---|
|
All Cause Mortality Through 60 Days Post-randomization.
Survival
|
12 Participants
|
|
All Cause Mortality Through 60 Days Post-randomization.
Non-survival
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 28 following treatmentPopulation: 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.
Mortality at day 28 following treatment
Outcome measures
| Measure |
Treatment
n=16 Participants
Treatment arm only
SCD-F40: CRRT with SCD
|
|---|---|
|
Mortality at Day 28
Survival
|
16 Participants
|
|
Mortality at Day 28
Non survival
|
0 Participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Survivors 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.
Outcome measures
| Measure |
Treatment
n=12 Participants
Treatment arm only
SCD-F40: CRRT with SCD
|
|---|---|
|
The Effect of SCD Treatment on Renal Replacement Therapy Dependency at Day 60.
Dialysis dependency
|
0 Participants
|
|
The Effect of SCD Treatment on Renal Replacement Therapy Dependency at Day 60.
No dialysis dependency
|
12 Participants
|
Adverse Events
CRRT + SCD
Serious events: 8 serious events
Other events: 14 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
CRRT + SCD
n=16 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
25.0%
4/16 • Number of events 4 • During and 60 Days Post Treatment Initiation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumoperitoneum
|
18.8%
3/16 • Number of events 3 • During and 60 Days Post Treatment Initiation.
|
|
Renal and urinary disorders
Nephrolithiasis
|
6.2%
1/16 • Number of events 1 • During and 60 Days Post Treatment Initiation.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
6.2%
1/16 • Number of events 1 • During and 60 Days Post Treatment Initiation.
|
|
Nervous system disorders
Cerebral Hemorrhage
|
6.2%
1/16 • Number of events 1 • During and 60 Days Post Treatment Initiation.
|
|
Endocrine disorders
Adrenal Insufficiency
|
6.2%
1/16 • Number of events 1 • During and 60 Days Post Treatment Initiation.
|
|
Vascular disorders
Vascular Graft Occlusion
|
6.2%
1/16 • Number of events 1 • During and 60 Days Post Treatment Initiation.
|
Other adverse events
| Measure |
CRRT + SCD
n=16 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.8%
3/16 • Number of events 3 • During and 60 Days Post Treatment Initiation.
|
|
Cardiac disorders
Tachycardia
|
18.8%
3/16 • Number of events 3 • During and 60 Days Post Treatment Initiation.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
31.2%
5/16 • Number of events 5 • During and 60 Days Post Treatment Initiation.
|
|
Vascular disorders
Hypertension
|
43.8%
7/16 • Number of events 7 • During and 60 Days Post Treatment Initiation.
|
|
Infections and infestations
Post procedure pneumonia
|
6.2%
1/16 • Number of events 1 • During and 60 Days Post Treatment Initiation.
|
|
Nervous system disorders
Cerebral hemorrhage
|
6.2%
1/16 • Number of events 1 • During and 60 Days Post Treatment Initiation.
|
|
General disorders
Hypothermia
|
31.2%
5/16 • Number of events 5 • During and 60 Days Post Treatment Initiation.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
6.2%
1/16 • Number of events 1 • During and 60 Days Post Treatment Initiation.
|
|
Injury, poisoning and procedural complications
Subcutaneous emphysema
|
6.2%
1/16 • Number of events 1 • During and 60 Days Post Treatment Initiation.
|
|
Psychiatric disorders
Intensive care unit delirium
|
6.2%
1/16 • Number of events 1 • During and 60 Days Post Treatment Initiation.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
12.5%
2/16 • Number of events 2 • During and 60 Days Post Treatment Initiation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place