Acute Kidney Injury, Septic Shock
Conditions
Keywords
Renal Replacement Therapy,, Cytokines, Efficiency
Brief summary
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.
Detailed description
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.
Interventions
DEVICEUltraflux® EMiC®2
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
Sponsors
International Renal Research Institute Vicenza
University of Giessen
Fiorenza Ferrari
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
Blinding procedure was limited to the doctors who collected the data and the external statistician who performed the analysis
Intervention model description
All patients received two consecutive RRT (MCO-CVVHD and HFF-CVVHDF); in a controlled randomized (1:1) blinded manner. Each RRT treatment lasted 24 hours Crossover randomized to sequence (A+B or B+A) for 48 h total without washout
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years; * septic shock according to ACCP/SCCM criteria * AKI KDIGO stage 3 * clinical decision to begin citrate based-RRT for at least 48 hours * Hb \>= 9 g/dL * Obtain the informed consent
Exclusion criteria
* Pre-existing chronic renal insufficiency * Weight \> 125 kg Life expectancy \<24 hr * Declared do Not Resuscitate or Comfort Measures * Platelets \< 20 \[10\^3/ul\] or active bleeding * Pregnancy * Contraindication to citrate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improvement in haemodynamic parameters | 48 hours | measurements of the hemodynamic parameters: mean arterial pressure (MAP, mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clerance of cytokine | 48 hours | removal of IL-6 (pg/mL) |
| Efficiency for middle molecules | 48 hours | 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. |
| Efficiency for small molecules | 48 hours | 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. |
| removal of antibiotics | 48 hours | evaluation of plasma level of vancomycin piperacillin/tazobactam(mcg/ml) |
Countries
Italy
Outcome results
None listed