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Completed

NCT Number: NCT04834921

MCO Membrane Efficiency in Septic Shock Patients

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.

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Key information

Conditions

Septic Shock Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fiorenza Ferrari

Pavia, PV, 27000, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultraflux® EMiC®2

Device

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

Primary outcomes

  1. improvement in haemodynamic parameters

    Time frame: 48 hours

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

  2. improvement in haemodynamic parameters

    Time frame: 48 hours

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

  3. improvement in haemodynamic parameters

    Time frame: 48 hours

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

  4. improvement in haemodynamic parameters

    Time frame: 48 hours

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

  5. improvement in haemodynamic parameters

    Time frame: 48 hours

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

  6. improvement in haemodynamic parameters

    Time frame: 48 hours

    measurements of the hemodynamic parameters: PVC (mmHg)

  7. improvement in haemodynamic parameters

    Time frame: 48 hours

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

  8. improvement in haemodynamic parameters

    Time frame: 48 hours

    measurements of the hemodynamic parameters: SCVO2 (%)

  9. improvement in haemodynamic parameters

    Time frame: 48 hours

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

Secondary outcomes

  1. clerance of cytokine

    Time frame: 48 hours

    removal of IL-6 (pg/mL)

  2. clerance of cytokine

    Time frame: 48 hours

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

  3. clerance of cytokine

    Time frame: 48 hours

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

  4. clerance of cytokine

    Time frame: 48 hours

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

  5. Efficiency for middle molecules

    Time frame: 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.

  6. Efficiency for small molecules

    Time frame: 48 hours

    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.

  7. Efficiency for small molecules

    Time frame: 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.

  8. removal of antibiotics

    Time frame: 48 hours

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

  9. removal of antibiotics

    Time frame: 48 hours

    evaluation of plasma level of vancomycin (mcg/ml)

  10. removal of antibiotics

    Time frame: 48 hours

    evaluation of plasma level of meropenem(mg/L)

Sponsors and collaborators

Lead sponsor

Fiorenza Ferrari

Other

Collaborators

  • International Renal Research Institute Vicenza
  • University of Giessen

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Apr 8, 2021
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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