MCO Membrane Efficiency in Septic Shock Patients

Not Applicable

Completed

• Conditions: Septic Shock; Acute Kidney Injury
• Interventions: Device: Ultraflux® EMiC®2

• Registration Number: NCT04834921
• Lead Sponsor: Fiorenza Ferrari

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.

Study Timeline

• Study Start: 2017-12-31
• Primary Completion: 2020-02-21
• Study Completion: 2021-01-31
• Study First Submitted: 2021-03-30
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-04
• Last Update Submitted: 2021-04-07
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MCO-CVVHD	Ultraflux® EMiC®2	CVVHD with MCO filter for 24 hours
HFF-CVVHDF	Ultraflux® EMiC®2	CVVHDF with high flux filter for 24 hours

Primary Outcome Measures

Name	Time	Method
improvement in haemodynamic parameters	48 hours	measurements of the hemodynamic parameters: dose of vasopressor or inotropes (mcg/kg/min)

Secondary Outcome Measures

Name	Time	Method
clerance of cytokine	48 hours	removal of MPO (U/L); reduction was evaluated after before and after the RRT
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 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.
removal of antibiotics	48 hours	evaluation of plasma level of meropenem(mg/L)

Trial Locations

Locations (1)

Fiorenza Ferrari; 🇮🇹 Pavia, PV, Italy