AzTrials
AzTrials

Septic ShockNCT04834921

MCO Membrane Efficiency in Septic Shock Patients

A study testing Ultraflux® EMiC®2 in people with Septic Shock and Acute Kidney Injury, run by Fiorenza Ferrari at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock, Acute Kidney Injury
What is being tested?
Ultraflux® EMiC®2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
31 Dec 2017to 31 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fiorenza Ferrari

    Pavia, PV, 27000

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Ultraflux® EMiC®2
Keywords
Renal Replacement Therapy,, Cytokines, Efficiency
Medical subject headings
Shock, Septic, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultraflux® EMiC®2Device

    Also called HFF-CVVHDF

    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

Study groups in NCT04834921
Study groupRoleWhat they receive
MCO-CVVHDExperimentalCVVHD with MCO filter for 24 hours
Receives: Device: Ultraflux® EMiC®2
HFF-CVVHDFActive comparatorCVVHDF with high flux filter for 24 hours
Receives: Device: Ultraflux® EMiC®2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. improvement in haemodynamic parameters

    measurements of the hemodynamic parameters: mean arterial pressure (MAP, mmHg)

    Measured: 48 hours

  2. improvement in haemodynamic parameters

    measurements of the hemodynamic parameters: heart rate (HR, beat/min)

    Measured: 48 hours

  3. improvement in haemodynamic parameters

    measurements of the hemodynamic parameters: lactate level (mmol/L)

    Measured: 48 hours

  4. improvement in haemodynamic parameters

    measurements of the hemodynamic parameters: cardiac index (CI; L/min/m2)

    Measured: 48 hours

  5. improvement in haemodynamic parameters

    measurements of the hemodynamic parameters: stroke volume variation (SVV; %)

    Measured: 48 hours

  6. improvement in haemodynamic parameters

    measurements of the hemodynamic parameters: PVC (mmHg)

    Measured: 48 hours

  7. improvement in haemodynamic parameters

    measurements of the hemodynamic parameters: SVRI (dyn*s/cm5*m2)

    Measured: 48 hours

  8. improvement in haemodynamic parameters

    measurements of the hemodynamic parameters: SCVO2 (%)

    Measured: 48 hours

  9. improvement in haemodynamic parameters

    measurements of the hemodynamic parameters: dose of vasopressor or inotropes (mcg/kg/min)

    Measured: 48 hours

Secondary outcomes (10)

  1. clerance of cytokine

    removal of IL-6 (pg/mL)

    Measured: 48 hours

  2. clerance of cytokine

    removal of IL-10 (pg/mL); reduction was evaluated after before and after the RRT

    Measured: 48 hours

  3. clerance of cytokine

    removal of IL-8 (pg/mL); reduction was evaluated after before and after the RRT

    Measured: 48 hours

  4. clerance of cytokine

    removal of MPO (U/L); reduction was evaluated after before and after the RRT

    Measured: 48 hours

  5. 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.

    Measured: 48 hours

  6. 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.

    Measured: 48 hours

  7. 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.

    Measured: 48 hours

  8. removal of antibiotics

    evaluation of plasma level of vancomycin piperacillin/tazobactam(mcg/ml)

    Measured: 48 hours

  9. removal of antibiotics

    evaluation of plasma level of vancomycin (mcg/ml)

    Measured: 48 hours

  10. removal of antibiotics

    evaluation of plasma level of meropenem(mg/L)

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start31 Dec 2017
  3. Primary completion21 Feb 2020
  4. Study completion31 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
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
Single blind
Who is masked
Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04834921
Sponsor's protocol ID
46/15A
Status last verified
Apr 2021
First submitted
30 Mar 2021
Last updated
12 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ferrari F, Milla P, Sartori M, Zanza C, Tesauro M, Longhitano Y, De Silvestri A, Abbruzzese C, De Rosa S, Lassola S, Samoni S, Brendolan A, Zanella M, Scaravilli V, Grasselli G, Arpicco S, Ronco C. Antibiotics Removal during Continuous Renal Replacement Therapy in Septic Shock Patients: Mixed Modality Versus "Expanded Haemodialysis". Clin Pharmacokinet. 2024 Aug;63(8):1167-1176. doi: 10.1007/s40262-024-01397-w. Epub 2024 Aug 5.

    PubMed 39102092

Questions about this trial

What is this clinical trial studying?

A study testing Ultraflux® EMiC®2 in people with Septic Shock and Acute Kidney Injury, run by Fiorenza Ferrari at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

improvement in haemodynamic parameters (time frame: 48 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04834921, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in