Evidence map›Paper›PMID 26244978›Full record

Trial reportPloS one2015

A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury.

James A Tumlin, Claude M Galphin, Ashita J Tolwani, Micah R Chan, Anitha Vijayan, Kevin Finkel, Balazs Szamosfalvi, Devasmita Dev, J Ricardo DaSilva, Brad C Astor and 3 more

3 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01400893 naterminatednot on this map

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)

TypeinterventionalSponsorSeaStar MedicalRan2011 to 2013Enrolled134ConditionsAcute Kidney InjuryArmsSCD
NCT04353674 nacompletednot on this mapstarted 2020, after this paper: background citation

Novel Extracorporeal Treatment to Modulate Hyperinflammation in COVID-19 Patients

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2020 to 2024Enrolled12ConditionsCOVID-19, SARSArmsControl group, SLEDD with a L-MOD
NCT05758077 narecruitingnot on this mapstarted 2023, after this paper: background citation

A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients With Acute Kidney Injury Requiring Continuous Kidney Replacement Therapy

TypeinterventionalSponsorSeaStar MedicalRan2023 to 2027Enrolled339ConditionsAcute Kidney InjuryArmsSelective Cytopheretic Device, Standard of Care
3 · Its place in the literature

Who cites it

37 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

James A TumlinDepartment of Medicine, UT College of Medicine, University of Tennessee, 960 East Third Street, Suite 100, Chattanooga, TN, 37403, United States of America.
Claude M GalphinDepartment of Medicine, UT College of Medicine, University of Tennessee, 960 East Third Street, Suite 100, Chattanooga, TN, 37403, United States of America.
Ashita J TolwaniDepartment of Medicine, UAB School of Medicine, University of Alabama, 1720 2nd Ave. S. FOT 1203, Birmingham, AL, 35294-3412, United States of America.
Micah R ChanDepartment of Medicine, University of Wisconsin, UW Med Fndtn. Centennial Bldg. 5148 MFCB, 1685 Highland Ave., Madison, WI, 53705-2281, United States of America.
Anitha VijayanWashington University School of Medicine, 660 S Euclid Ave., St Louis, MO, 63110, United States of America.
Kevin FinkelUT Health Science Center, University of Texas, 6410 Fannin St., Ste. 606, Houston, TX, 77030, United States of America.
Balazs SzamosfalviHenry Ford Health System, Henry Ford Hospital, CFP-509, 2799 West Grand Blvd., Detroit, MI, 48202-2608, United States of America.
Devasmita DevDallas VA Medical Center, 4500 S. Lancaster Rd., Dallas, TX, 75216, United States of America.
J Ricardo DaSilvaCytoPherx, Inc., 401 W. Morgan Rd., Ann Arbor, MI, 48108, United States of America.
Brad C AstorDepartment of Medicine, University of Wisconsin, UW Med Fndtn. Centennial Bldg. 5148 MFCB, 1685 Highland Ave., Madison, WI, 53705-2281, United States of America; Department of Population Health Sciences, University of Wisconsin, Health Sciences Learning Center, 750 Highland Ave., Madison, WI, 53705, United States of America.
Alexander S YevzlinDepartment of Medicine, University of Wisconsin, UW Med Fndtn. Centennial Bldg. 5148 MFCB, 1685 Highland Ave., Madison, WI, 53705-2281, United States of America; CytoPherx, Inc., 401 W. Morgan Rd., Ann Arbor, MI, 48108, United States of America.
H David HumesCytoPherx, Inc., 401 W. Morgan Rd., Ann Arbor, MI, 48108, United States of America; Department of Medicine, University of Michigan, 4520 MSRB I, Box 0651, 1150 W. Medical Center Drive, Ann Arbor, MI, 48109, United States of America.
SCD Investigator Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAcute kidney injury (AKI) is a highly morbid condition in critically ill patients that is associated with high mortality. Previous clinical studies have demonstrated the safety and efficacy of the Selective Cytopheretic Device (SCD) in the treatment of AKI requiring continuous renal replacement therapy in the intensive care unit (ICU). DESIGN, SETTING, PATIENTS: A randomized, controlled trial of 134 ICU patients with AKI, 69 received continuous renal replacement therapy (CRRT) alone and 65 received SCD therapy.

resultsNo significant difference in 60-day mortality was observed between the treated (27/69; 39%) and control patients (21/59; 36%, with six patients lost to follow up) in the intention to treat (ITT) analysis. Of the 19 SCD subjects (CRRT+SCD) and 31 control subjects (CRRT alone) who maintained a post-filter ionized calcium (iCa) level in the protocol's recommended range (≤ 0.4 mmol/L) for greater or equal to 90% of the therapy time, 60-day mortality was 16% (3/19) in the SCD group compared to 41% (11/27) in the CRRT alone group (p = 0.11). Dialysis dependency showed a borderline statistically significant difference between the SCD treated versus control CRRT alone patients maintained for ≥ 90% of the treatment in the protocol's recommended (r) iCa target range of ≤ 0.4 mmol/L with values of, 0% (0/16) and 25% (4/16), respectively (P = 0.10). When the riCa treated and control subgroups were compared for a composite index of 60 day mortality and dialysis dependency, the percentage of SCD treated subjects was 16% versus 58% in the control subjects (p<0.01). The incidence of serious adverse events did not differ between the treated (45/69; 65%) and control groups (40/65; 63%; p = 0·86).

conclusionSCD therapy may improve mortality and reduce dialysis dependency in a tightly controlled regional hypocalcaemic environment in the perfusion circuit.

trial registrationClinicalTrials.gov NCT01400893 http://clinicaltrials.gov/ct2/show/NCT01400893.

Indexed as

Renal DialysisAcute Kidney InjuryAdultAgedCritical CareFemaleHumansMaleMiddle AgedRenal Replacement TherapyTreatment Outcome

Identifiers

PMID26244978
PMCPMC4526678

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.