MCO Membrane Efficiency in Septic Shock Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock; Acute Kidney Injury
• Intervention / Treatment: Device: Ultraflux® EMiC®2

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PV
    • Pavia, PV, Italy, 27000
      • Fiorenza Ferrari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MCO-CVVHD; CVVHD with MCO filter for 24 hours	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; Other Names: HFF-CVVHDF
Active Comparator: HFF-CVVHDF; CVVHDF with high flux filter for 24 hours	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; Other Names: HFF-CVVHDF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement in haemodynamic parameters	measurements of the hemodynamic parameters: mean arterial pressure (MAP, mmHg)	48 hours
improvement in haemodynamic parameters	measurements of the hemodynamic parameters: heart rate (HR, beat/min)	48 hours
improvement in haemodynamic parameters	measurements of the hemodynamic parameters: lactate level (mmol/L)	48 hours
improvement in haemodynamic parameters	measurements of the hemodynamic parameters: cardiac index (CI; L/min/m2)	48 hours
improvement in haemodynamic parameters	measurements of the hemodynamic parameters: stroke volume variation (SVV; %)	48 hours
improvement in haemodynamic parameters	measurements of the hemodynamic parameters: PVC (mmHg)	48 hours
improvement in haemodynamic parameters	measurements of the hemodynamic parameters: SVRI (dyn*s/cm5*m2)	48 hours
improvement in haemodynamic parameters	measurements of the hemodynamic parameters: SCVO2 (%)	48 hours
improvement in haemodynamic parameters	measurements of the hemodynamic parameters: dose of vasopressor or inotropes (mcg/kg/min)	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clerance of cytokine	removal of IL-6 (pg/mL)	48 hours
clerance of cytokine	removal of IL-10 (pg/mL); reduction was evaluated after before and after the RRT	48 hours
clerance of cytokine	removal of IL-8 (pg/mL); reduction was evaluated after before and after the RRT	48 hours
clerance of cytokine	removal of MPO (U/L); reduction was evaluated after before and after the RRT	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.	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.	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.	48 hours
removal of antibiotics	evaluation of plasma level of vancomycin piperacillin/tazobactam(mcg/ml)	48 hours
removal of antibiotics	evaluation of plasma level of vancomycin (mcg/ml)	48 hours
removal of antibiotics	evaluation of plasma level of meropenem(mg/L)	48 hours

Collaborators and Investigators

• Sponsor: Fiorenza Ferrari
• Collaborators: University of Giessen; International Renal Research Institute Vicenza

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2017
• Primary Completion (Actual): February 21, 2020
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 4, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Cytokines; Efficiency; Renal Replacement Therapy,
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Kidney Diseases; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Shock; Sepsis; Shock, Septic; Acute Kidney Injury
• Other Study ID Numbers: 46/15A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No