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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 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 Gro - PLoS ONE (2015)

Bottom Line: 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).SCD therapy may improve mortality and reduce dialysis dependency in a tightly controlled regional hypocalcaemic environment in the perfusion circuit.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, UT College of Medicine, University of Tennessee, 960 East Third Street, Suite 100, Chattanooga, TN, 37403, United States of America.

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 (≤ 0.4 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).

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

Trial registration: ClinicalTrials.gov NCT01400893 http://clinicaltrials.gov/ct2/show/NCT01400893.

No MeSH data available.


Related in: MedlinePlus

Flow chart of the disposition in all of the patients (N = 134) enrolled.For the purpose of statistical analysis ITT is defined as all control and all treatment, whereas mITT is defined as all control and all treatment with iCa at recommended range >90% of the time.
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pone.0132482.g001: Flow chart of the disposition in all of the patients (N = 134) enrolled.For the purpose of statistical analysis ITT is defined as all control and all treatment, whereas mITT is defined as all control and all treatment with iCa at recommended range >90% of the time.

Mentions: Patients randomized to the control arm received renal replacement therapy utilizing a CRRT pump system that is identical to that used for the SCD treatment, tubing and hemofilter provided by the sponsor (CytoPherx, Inc., Ann Arbor, MI). Anticoagulation of the system was accomplished using the institution’s protocol for citrate anticoagulation with a target range for intra-circuit ionized calcium of 0·25–0·40 mmol/L. All patients in the control arm were required to use citrate as an anticoagulant. Patients randomized to the study treatment arm received renal replacement therapy identical to the control arm, plus the SCD (Fig 1). The SCD was placed in the CRRT blood circuit as detailed (S1 Fig).


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 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 Gro - PLoS ONE (2015)

Flow chart of the disposition in all of the patients (N = 134) enrolled.For the purpose of statistical analysis ITT is defined as all control and all treatment, whereas mITT is defined as all control and all treatment with iCa at recommended range >90% of the time.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4526678&req=5

pone.0132482.g001: Flow chart of the disposition in all of the patients (N = 134) enrolled.For the purpose of statistical analysis ITT is defined as all control and all treatment, whereas mITT is defined as all control and all treatment with iCa at recommended range >90% of the time.
Mentions: Patients randomized to the control arm received renal replacement therapy utilizing a CRRT pump system that is identical to that used for the SCD treatment, tubing and hemofilter provided by the sponsor (CytoPherx, Inc., Ann Arbor, MI). Anticoagulation of the system was accomplished using the institution’s protocol for citrate anticoagulation with a target range for intra-circuit ionized calcium of 0·25–0·40 mmol/L. All patients in the control arm were required to use citrate as an anticoagulant. Patients randomized to the study treatment arm received renal replacement therapy identical to the control arm, plus the SCD (Fig 1). The SCD was placed in the CRRT blood circuit as detailed (S1 Fig).

Bottom Line: 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).SCD therapy may improve mortality and reduce dialysis dependency in a tightly controlled regional hypocalcaemic environment in the perfusion circuit.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, UT College of Medicine, University of Tennessee, 960 East Third Street, Suite 100, Chattanooga, TN, 37403, United States of America.

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 (≤ 0.4 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).

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

Trial registration: ClinicalTrials.gov NCT01400893 http://clinicaltrials.gov/ct2/show/NCT01400893.

No MeSH data available.


Related in: MedlinePlus