search
Back to results

MCO Membrane Efficiency in Septic Shock Patients

Primary Purpose

Septic Shock, Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ultraflux® EMiC®2
Sponsored by
Fiorenza Ferrari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Septic Shock focused on measuring Renal Replacement Therapy,, Cytokines, Efficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fiorenza Ferrari

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MCO-CVVHD

HFF-CVVHDF

Arm Description

CVVHD with MCO filter for 24 hours

CVVHDF with high flux filter for 24 hours

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 30, 2021
Last Updated
April 7, 2021
Sponsor
Fiorenza Ferrari
Collaborators
International Renal Research Institute Vicenza, University of Giessen
search

1. Study Identification

Unique Protocol Identification Number
NCT04834921
Brief Title
MCO Membrane Efficiency in Septic Shock Patients
Official Title
Randomized Blinded Controlled Pilot Study on Clinical Assessment of Continuous Hemodialysis With a High Molecular Flux Membrane
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 31, 2017 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fiorenza Ferrari
Collaborators
International Renal Research Institute Vicenza, University of Giessen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Acute Kidney Injury
Keywords
Renal Replacement Therapy,, Cytokines, Efficiency

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Masking
Investigator
Masking Description
Blinding procedure was limited to the doctors who collected the data and the external statistician who performed the analysis
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCO-CVVHD
Arm Type
Experimental
Arm Description
CVVHD with MCO filter for 24 hours
Arm Title
HFF-CVVHDF
Arm Type
Active Comparator
Arm Description
CVVHDF with high flux filter for 24 hours
Intervention Type
Device
Intervention Name(s)
Ultraflux® EMiC®2
Other Intervention Name(s)
HFF-CVVHDF
Intervention Description
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
Primary Outcome Measure Information:
Title
improvement in haemodynamic parameters
Description
measurements of the hemodynamic parameters: mean arterial pressure (MAP, mmHg)
Time Frame
48 hours
Title
improvement in haemodynamic parameters
Description
measurements of the hemodynamic parameters: heart rate (HR, beat/min)
Time Frame
48 hours
Title
improvement in haemodynamic parameters
Description
measurements of the hemodynamic parameters: lactate level (mmol/L)
Time Frame
48 hours
Title
improvement in haemodynamic parameters
Description
measurements of the hemodynamic parameters: cardiac index (CI; L/min/m2)
Time Frame
48 hours
Title
improvement in haemodynamic parameters
Description
measurements of the hemodynamic parameters: stroke volume variation (SVV; %)
Time Frame
48 hours
Title
improvement in haemodynamic parameters
Description
measurements of the hemodynamic parameters: PVC (mmHg)
Time Frame
48 hours
Title
improvement in haemodynamic parameters
Description
measurements of the hemodynamic parameters: SVRI (dyn*s/cm5*m2)
Time Frame
48 hours
Title
improvement in haemodynamic parameters
Description
measurements of the hemodynamic parameters: SCVO2 (%)
Time Frame
48 hours
Title
improvement in haemodynamic parameters
Description
measurements of the hemodynamic parameters: dose of vasopressor or inotropes (mcg/kg/min)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
clerance of cytokine
Description
removal of IL-6 (pg/mL)
Time Frame
48 hours
Title
clerance of cytokine
Description
removal of IL-10 (pg/mL); reduction was evaluated after before and after the RRT
Time Frame
48 hours
Title
clerance of cytokine
Description
removal of IL-8 (pg/mL); reduction was evaluated after before and after the RRT
Time Frame
48 hours
Title
clerance of cytokine
Description
removal of MPO (U/L); reduction was evaluated after before and after the RRT
Time Frame
48 hours
Title
Efficiency for middle molecules
Description
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
Title
Efficiency for small molecules
Description
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
Title
Efficiency for small molecules
Description
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
Title
removal of antibiotics
Description
evaluation of plasma level of vancomycin piperacillin/tazobactam(mcg/ml)
Time Frame
48 hours
Title
removal of antibiotics
Description
evaluation of plasma level of vancomycin (mcg/ml)
Time Frame
48 hours
Title
removal of antibiotics
Description
evaluation of plasma level of meropenem(mg/L)
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fiorenza Ferrari
City
Pavia
State/Province
PV
ZIP/Postal Code
27000
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MCO Membrane Efficiency in Septic Shock Patients

We'll reach out to this number within 24 hrs