Trial Outcomes & Findings for Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure (NCT NCT01072682)
NCT ID: NCT01072682
Last Updated: 2022-03-31
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Day 60 following treatment end
Results posted on
2022-03-31
Participant Flow
Participant milestones
| Measure |
SCD Experimental Treatment Arm
Selective Cytopheretic Device
Selective cytopheretic device (SCD): The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter 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 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
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure
Baseline characteristics by cohort
| Measure |
SCD Experimental Treatment Arm
n=35 Participants
Selective Cytopheretic Device
Selective cytopheretic device (SCD): The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter 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 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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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 60 following treatment endOutcome measures
| Measure |
SCD Experimental Treatment Arm
n=35 Participants
Selective Cytopheretic Device
Selective cytopheretic device (SCD): The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter 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 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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|---|---|
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60 Day Mortality
|
11 Participants
|
PRIMARY outcome
Timeframe: Day 60 following treatment endPopulation: Renal Recovery in surviving subjects at Day 60
The criteria used to measure Renal Recovery requires the patient to be dependent free of CRRT and/or chronic dialysis.
Outcome measures
| Measure |
SCD Experimental Treatment Arm
n=24 Participants
Selective Cytopheretic Device
Selective cytopheretic device (SCD): The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter 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 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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|---|---|
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60 Day Renal Recovery
|
24 Participants
|
Adverse Events
SCD Experimental Treatment Arm
Serious events: 23 serious events
Other events: 33 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
SCD Experimental Treatment Arm
n=35 participants at risk
Selective Cytopheretic Device
Selective cytopheretic device (SCD): The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter 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 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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|---|---|
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Vascular disorders
Right Iliac Artery Injury
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Complicated Abdominal Wound
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Septic Shock
|
2.9%
1/35 • Number of events 1
|
|
Cardiac disorders
Cardiogenic Shock
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Sepsis
|
8.6%
3/35 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
5.7%
2/35 • Number of events 2
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
2.9%
1/35 • Number of events 1
|
|
Cardiac disorders
Ventricular Fibrillation
|
2.9%
1/35 • Number of events 1
|
|
Blood and lymphatic system disorders
DIC
|
5.7%
2/35 • Number of events 2
|
|
General disorders
Multi-System Organ Failure
|
8.6%
3/35 • Number of events 3
|
|
Blood and lymphatic system disorders
Pulmonary Thromboembolism
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
GI Bleed
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
5.7%
2/35 • Number of events 2
|
|
Surgical and medical procedures
Chest Tube Bleed
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Empyema
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Nutritional Deficiency
|
2.9%
1/35 • Number of events 1
|
|
Blood and lymphatic system disorders
Multifactorial Anemia
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Multiple Spontaneous Pneumothoraces
|
2.9%
1/35 • Number of events 1
|
|
Psychiatric disorders
Altered Mental Status
|
2.9%
1/35 • Number of events 1
|
Other adverse events
| Measure |
SCD Experimental Treatment Arm
n=35 participants at risk
Selective Cytopheretic Device
Selective cytopheretic device (SCD): The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter 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 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
|
25.7%
9/35 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.7%
2/35 • Number of events 2
|
|
Cardiac disorders
Hypotension
|
20.0%
7/35 • Number of events 7
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
7/35 • Number of events 7
|
|
Metabolism and nutrition disorders
Leukocytosis
|
11.4%
4/35 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
11.4%
4/35 • Number of events 4
|
|
Metabolism and nutrition disorders
Metabolic Alkalosis
|
5.7%
2/35 • Number of events 2
|
|
Metabolism and nutrition disorders
Respiratory Alkalosis
|
8.6%
3/35 • Number of events 3
|
|
Blood and lymphatic system disorders
Non-occlusive Thrombus
|
5.7%
2/35 • Number of events 2
|
|
Infections and infestations
Candidiasis
|
11.4%
4/35 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.4%
4/35 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.7%
2/35 • Number of events 2
|
|
Cardiac disorders
Ventricular Tachycardia
|
8.6%
3/35 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.7%
2/35 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.3%
5/35 • Number of events 5
|
|
Cardiac disorders
Bradycardia
|
5.7%
2/35 • Number of events 2
|
|
Endocrine disorders
Hypoglycemia
|
5.7%
2/35 • Number of events 2
|
|
Cardiac disorders
Atrial Fibrillation
|
11.4%
4/35 • Number of events 4
|
|
General disorders
Hematoma
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
Rectal Bleed
|
11.4%
4/35 • Number of events 4
|
|
Infections and infestations
Sepsis
|
8.6%
3/35 • Number of events 3
|
|
General disorders
Generalized Pain
|
11.4%
4/35 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.7%
2/35 • Number of events 2
|
|
General disorders
Agitation
|
11.4%
4/35 • Number of events 4
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis (DVT)
|
8.6%
3/35 • Number of events 3
|
|
Cardiac disorders
Sinus Tachycardia
|
8.6%
3/35 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.6%
3/35 • Number of events 3
|
|
General disorders
Hypervolemia
|
11.4%
4/35 • Number of events 4
|
|
Infections and infestations
Pneumonia
|
5.7%
2/35 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
5.7%
2/35 • Number of events 2
|
|
General disorders
Encephalopathy
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
Ileus
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
5.7%
2/35 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.7%
2/35 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place