MCO Membrane Efficiency in Septic Shock Patients

Fiorenza Ferrari

Status: Completed

Conditions: Acute Kidney Injury; Septic Shock

Treatments: Device: Ultraflux® EMiC®2

Study type: Interventional

Funder types: Other

Identifiers

NCT04834921

46/15A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

MCO-CVVHD

Experimental group

Description:

CVVHD with MCO filter for 24 hours

Treatment:

Device: Ultraflux® EMiC®2

HFF-CVVHDF

Active Comparator group

Description:

CVVHDF with high flux filter for 24 hours

Treatment:

Device: Ultraflux® EMiC®2