This is a monocentre randomized pilot study. All patients received two consecutive RRT: CVVHD with MCO filter (Ultraflux® EMiC®2) and post-Continuous Veno-Venous Hemodiafiltration (CVVHDF) with HFF(AV1000S®) in a controlled randomized (1:1) blinded manner. Crossover randomized to sequence (A+B or B+A) for 48 h total without washout.
This is a monocentre randomized pilot study. All patients received CVVHD with MCO filter (Ultraflux® EMiC®2) and post-Continuous Veno-Venous Hemodiafiltration (CVVHDF) with HFF(AV1000S®) in a controlled randomized (1:1) blinded manner. Crossover randomized to sequence (A+B or B+A) for 48 h total without washout. The efficiency of the filters for small and middle molecules was compared in septic shock patients with AKI stage 3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
20
Ultraflux® EMiC®2-CVVHD runs in septic shock patients with AKI KDIGO 3 for 24 hours. and patients were randomised to start Ultraflux® EMiC®2-CVVHD in the first day or in the second day from the RRT start; more precisely, crossover randomized to sequence consists in Ultraflux® EMiC®2-CVVHD (first day)+ HFF-CVVHDF(second day) and HFF-CVVHDF (first day) + Ultraflux® EMiC®2-CVVHD (second day) for 48 h total without washout
Fiorenza Ferrari
Pavia, PV, Italy
improvement in haemodynamic parameters
measurements of the hemodynamic parameters: mean arterial pressure (MAP, mmHg)
Time frame: 48 hours
improvement in haemodynamic parameters
measurements of the hemodynamic parameters: heart rate (HR, beat/min)
Time frame: 48 hours
improvement in haemodynamic parameters
measurements of the hemodynamic parameters: lactate level (mmol/L)
Time frame: 48 hours
improvement in haemodynamic parameters
measurements of the hemodynamic parameters: cardiac index (CI; L/min/m2)
Time frame: 48 hours
improvement in haemodynamic parameters
measurements of the hemodynamic parameters: stroke volume variation (SVV; %)
Time frame: 48 hours
improvement in haemodynamic parameters
measurements of the hemodynamic parameters: PVC (mmHg)
Time frame: 48 hours
improvement in haemodynamic parameters
measurements of the hemodynamic parameters: SVRI (dyn\*s/cm5\*m2)
Time frame: 48 hours
improvement in haemodynamic parameters
measurements of the hemodynamic parameters: SCVO2 (%)
Time frame: 48 hours
improvement in haemodynamic parameters
measurements of the hemodynamic parameters: dose of vasopressor or inotropes (mcg/kg/min)
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Time frame: 48 hours
clerance of cytokine
removal of IL-6 (pg/mL)
Time frame: 48 hours
clerance of cytokine
removal of IL-10 (pg/mL); reduction was evaluated after before and after the RRT
Time frame: 48 hours
clerance of cytokine
removal of IL-8 (pg/mL); reduction was evaluated after before and after the RRT
Time frame: 48 hours
clerance of cytokine
removal of MPO (U/L); reduction was evaluated after before and after the RRT
Time frame: 48 hours
Efficiency for middle molecules
measure of the efficacy (Kcd, (ml/kg/h)) of removal of B2microglobulin for each filter according to equation in Neri M, Villa G, Garzotto F, Bagshaw S, Bellomo R, Cerda J, Ferrari F, Guggia S, Joannidis M, Kellum J, Kim JC, Mehta RL, Ricci Z, Trevisani A, Marafon S, Clark WR, Vincent JL, Ronco C; Nomenclature Standardization Initiative (NSI) alliance. Nomenclature for renal replacement therapy in acute kidney injury: basic principles. Crit Care. 2016 Oct 10;20(1):318. Review.
Time frame: 48 hours
Efficiency for small molecules
measure of the efficacy (Kcd (ml/kg/h)) of BUN for each filter according to equation in Neri M, Villa G, Garzotto F, Bagshaw S, Bellomo R, Cerda J, Ferrari F, Guggia S, Joannidis M, Kellum J, Kim JC, Mehta RL, Ricci Z, Trevisani A, Marafon S, Clark WR, Vincent JL, Ronco C; Nomenclature Standardization Initiative (NSI) alliance. Nomenclature for renal replacement therapy in acute kidney injury: basic principles. Crit Care. 2016 Oct 10;20(1):318. Review.
Time frame: 48 hours
Efficiency for small molecules
measure of Efficacy (Kcd Cr (ml/kg/h)) of removal of SCr for each filter according to equation in Neri M, Villa G, Garzotto F, Bagshaw S, Bellomo R, Cerda J, Ferrari F, Guggia S, Joannidis M, Kellum J, Kim JC, Mehta RL, Ricci Z, Trevisani A, Marafon S, Clark WR, Vincent JL, Ronco C; Nomenclature Standardization Initiative (NSI) alliance. Nomenclature for renal replacement therapy in acute kidney injury: basic principles. Crit Care. 2016 Oct 10;20(1):318. Review.
Time frame: 48 hours
removal of antibiotics
evaluation of plasma level of vancomycin piperacillin/tazobactam(mcg/ml)
Time frame: 48 hours
removal of antibiotics
evaluation of plasma level of vancomycin (mcg/ml)
Time frame: 48 hours
removal of antibiotics
evaluation of plasma level of meropenem(mg/L)
Time frame: 48 hours