Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury

Acute Kidney Injury Clinical Trial

Official title:

A Multi-Center, Randomized, Controlled, Pivotal Study To Assess the Safety and Efficacy of A Selective Cytopheretic Device (SCD) In Patients With Acute Kidney Injury (AKI)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01400893
• Other study ID #: SCD-003
• Status: Terminated
• Phase: N/A
• Start date: August 2011
• Est. completion date: September 2013

Study information

• Verified date: April 2021
• Source: SeaStar Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this protocol is to evaluate the safety of a selective cytopheretic device (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute kidney injury (AKI).

Description:

Acute kidney injury is a condition where the kidneys are not capable of producing adequate urine. Therefore, another way to remove waste from the body is needed to hopefully allow time for the kidneys to heal. One method of removing waste from the body is called Continuous Renal Replacement Therapy (CRRT) or variations of that therapy. This study will evaluate the safety of the device while it is connected to the CRRT tubing for up to 7 days. Patients will be followed up until day 60 following the treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 134
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 18 to 80 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. Must be receiving and tolerating CRRT therapy for a minimum of 4 hours, but not longer than 24.

6. Expected to remain in the ICU for at least 96 hours after evaluation for enrollment.

7. A clinical diagnosis of ATN due to hemodynamic or toxic etiologies. ATN is defined as Acute Kidney Injury occurring in a setting of acute ischemic or nephrotoxic injury with oliguria (average <20 mL/hr) for >6-12 hours or: an increase in serum creatinine =2 mg/dL (=1.5 mg/dL in females) over a period of =4 days. (Note: Prerenal, hepatorenal, vascular, interstitial, glomerular, and obstructive etiologies are excluded on clinical or other diagnostic grounds.)

8. Presence of at least one non-renal organ failure or present sepsis as defined in Appendix C.

9. All patients must be able to tolerate regional citrate anticoagulation.

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.

4. Presence of preexisting advanced chronic renal failure (i.e., ESRD) requiring chronic renal replacement therapy prior to this episode of acute kidney injury.

5. AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, cyclosporine or tacrolimus nephrotoxicity.

6. Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after study therapy.

7. Chronic immunosuppression (e.g., HIV/AIDS, chronic glucocorticoid therapy >20 mg/day prednisone equivalent on a chronic basis). The acute use of glucocorticoids is permissible.

8. Severe liver failure as documented by a Child-Pugh Liver Failure Score >12 (see Appendix F).

9. Currently in Do Not Resuscitate (DNR) status or DNR status anticipated within the next 7 days.

10. Currently in Comfort measures Only or Comfort Measures Only status anticipated within next 7 days.

11. Patient is moribund or chronically debilitated for whom full supportive care is not indicated.

12. 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.)

13. Any medical condition that the Investigator thinks may interfere with the study objectives.

14. Physician refusal.

15. Patient is a prisoner.

16. Dry weight of >150 kg.

17. More than one hemodialysis treatment during this hospital admission or prior to transfer from an outside hospital.

18. Platelet count <30,000/mm3 at time of screening.

19. 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.

20. Use of any other Investigational drug or device within the previous 30 days.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Beth Isreal Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University Of South Carolina	Charleston	South Carolina
United States	Erlanger Hospital	Chattanooga	Tennessee
United States	Memorial Hospital	Chattanooga	Tennessee
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Dallas VA Medical Center	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	INOVA Health Care Services	Falls Church	Virginia
United States	Sanford Health	Fargo	North Dakota
United States	University of Florida	Gainesville	Florida
United States	University of Texas	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	University of Mississippi	Jackson	Mississippi
United States	University of Florida	Jacksonville	Florida
United States	UCLA	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Mount Sinai School of Medicine	New York	New York
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Washington University	Saint Louis	Missouri
United States	University of California, San Diego	San Diego	California
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
SeaStar Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tumlin JA, Galphin CM, Tolwani AJ, Chan MR, Vijayan A, Finkel K, Szamosfalvi B, Dev D, DaSilva JR, Astor BC, Yevzlin AS, Humes HD; SCD Investigator Group. A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selecti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Clinical Efficacy Endpoint in This Trial is All Cause Mortality Through 60 Days Post-randomization.	All cause mortality through day 60 post-randomization.; The outcome data reported here describe the mortality at Day 60 (primary endpoint) of the treated subjects which received the recommended ionized calcium (riCa) for = 90% of treatment time.	Day 60 following treatment initiation
Secondary	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.	Day 60 following treatment initiation

External Links

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