MCO Membrane Efficiency in Septic Shock Patients

Acute Kidney Injury Clinical Trial

Official title:

Randomized Blinded Controlled Pilot Study on Clinical Assessment of Continuous Hemodialysis With a High Molecular Flux Membrane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04834921
• Other study ID #: 46/15A
• Status: Completed
• Phase: N/A
• Start date: December 31, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2021
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2021
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Septic Shock
• Shock
• Shock, Septic

Intervention

Device:
• Ultraflux® 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

Locations

Country	Name	City	State
Italy	Fiorenza Ferrari	Pavia	PV

Sponsors (3)

Lead Sponsor	Collaborator
Fiorenza Ferrari	International Renal Research Institute Vicenza, University of Giessen

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in haemodynamic parameters	measurements of the hemodynamic parameters: mean arterial pressure (MAP, mmHg)	48 hours
Primary	improvement in haemodynamic parameters	measurements of the hemodynamic parameters: heart rate (HR, beat/min)	48 hours
Primary	improvement in haemodynamic parameters	measurements of the hemodynamic parameters: lactate level (mmol/L)	48 hours
Primary	improvement in haemodynamic parameters	measurements of the hemodynamic parameters: cardiac index (CI; L/min/m2)	48 hours
Primary	improvement in haemodynamic parameters	measurements of the hemodynamic parameters: stroke volume variation (SVV; %)	48 hours
Primary	improvement in haemodynamic parameters	measurements of the hemodynamic parameters: PVC (mmHg)	48 hours
Primary	improvement in haemodynamic parameters	measurements of the hemodynamic parameters: SVRI (dyn*s/cm5*m2)	48 hours
Primary	improvement in haemodynamic parameters	measurements of the hemodynamic parameters: SCVO2 (%)	48 hours
Primary	improvement in haemodynamic parameters	measurements of the hemodynamic parameters: dose of vasopressor or inotropes (mcg/kg/min)	48 hours
Secondary	clerance of cytokine	removal of IL-6 (pg/mL)	48 hours
Secondary	clerance of cytokine	removal of IL-10 (pg/mL); reduction was evaluated after before and after the RRT	48 hours
Secondary	clerance of cytokine	removal of IL-8 (pg/mL); reduction was evaluated after before and after the RRT	48 hours
Secondary	clerance of cytokine	removal of MPO (U/L); reduction was evaluated after before and after the RRT	48 hours
Secondary	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.	48 hours
Secondary	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.	48 hours
Secondary	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.	48 hours
Secondary	removal of antibiotics	evaluation of plasma level of vancomycin piperacillin/tazobactam(mcg/ml)	48 hours
Secondary	removal of antibiotics	evaluation of plasma level of vancomycin (mcg/ml)	48 hours
Secondary	removal of antibiotics	evaluation of plasma level of meropenem(mg/L)	48 hours