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, Alexander S. Yevzlin, H. David Humes

Research output: Contribution to journalArticle

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Abstract

Objective: Acute 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. Results: No 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 (≤ 0.4mmol/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). Conclusion: SCD therapy may improve mortality and reduce dialysis dependency in a tightly controlled regional hypocalcaemic environment in the perfusion circuit.

Original languageEnglish (US)
Article numbere0132482
JournalPLoS One
Volume10
Issue number8
DOIs
StatePublished - Aug 5 2015

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Acute Kidney Injury
Renal Replacement Therapy
kidneys
Safety
Equipment and Supplies
therapeutics
Dialysis
Intensive care units
Mortality
dialysis
Calcium
Intensive Care Units
Intention to Treat Analysis
calcium
Lost to Follow-Up
Therapeutics
Clinical Protocols
Critical Illness
Randomized Controlled Trials
Networks (circuits)

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Cite this

A multi-center, randomized, controlled, pivotal study to assess the safety and efficacy of a selective cytopheretic device in patients with acute kidney injury. / Tumlin, James A.; Galphin, Claude M.; Tolwani, Ashita J.; Chan, Micah R.; Vijayan, Anitha; Finkel, Kevin; Szamosfalvi, Balazs; Dev, Devasmita; Dasilva, J. Ricardo; Astor, Brad C.; Yevzlin, Alexander S.; Humes, H. David.

In: PLoS One, Vol. 10, No. 8, e0132482, 05.08.2015.

Research output: Contribution to journalArticle

Tumlin, JA, Galphin, CM, Tolwani, AJ, Chan, MR, Vijayan, A, Finkel, K, Szamosfalvi, B, Dev, D, Dasilva, JR, Astor, BC, Yevzlin, AS & Humes, HD 2015, 'A multi-center, randomized, controlled, pivotal study to assess the safety and efficacy of a selective cytopheretic device in patients with acute kidney injury', PLoS One, vol. 10, no. 8, e0132482. https://doi.org/10.1371/journal.pone.0132482
Tumlin, James A. ; Galphin, Claude M. ; Tolwani, Ashita J. ; Chan, Micah R. ; Vijayan, Anitha ; Finkel, Kevin ; Szamosfalvi, Balazs ; Dev, Devasmita ; Dasilva, J. Ricardo ; Astor, Brad C. ; Yevzlin, Alexander S. ; Humes, H. David. / A multi-center, randomized, controlled, pivotal study to assess the safety and efficacy of a selective cytopheretic device in patients with acute kidney injury. In: PLoS One. 2015 ; Vol. 10, No. 8.
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abstract = "Objective: Acute 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. Results: No 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 (≤ 0.4mmol/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). Conclusion: SCD therapy may improve mortality and reduce dialysis dependency in a tightly controlled regional hypocalcaemic environment in the perfusion circuit.",
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AU - Galphin, Claude M.

AU - Tolwani, Ashita J.

AU - Chan, Micah R.

AU - Vijayan, Anitha

AU - Finkel, Kevin

AU - Szamosfalvi, Balazs

AU - Dev, Devasmita

AU - Dasilva, J. Ricardo

AU - Astor, Brad C.

AU - Yevzlin, Alexander S.

AU - Humes, H. David

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N2 - Objective: Acute 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. Results: No 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 (≤ 0.4mmol/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). Conclusion: SCD therapy may improve mortality and reduce dialysis dependency in a tightly controlled regional hypocalcaemic environment in the perfusion circuit.

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