Clinical trial NCT04834921: 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
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Acute Kidney Injury
Keywords: Renal Replacement Therapy,
Cytokines
Efficiency
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: International Renal Research Institute Vicenza
name: University of Giessen
First posted: 2021-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: improvement in haemodynamic parameters
timeFrame: 48 hours
measure: improvement in haemodynamic parameters
timeFrame: 48 hours
measure: improvement in haemodynamic parameters
timeFrame: 48 hours
measure: improvement in haemodynamic parameters
timeFrame: 48 hours
measure: improvement in haemodynamic parameters
timeFrame: 48 hours
measure: improvement in haemodynamic parameters
timeFrame: 48 hours
measure: improvement in haemodynamic parameters
timeFrame: 48 hours
measure: improvement in haemodynamic parameters
timeFrame: 48 hours
measure: improvement in haemodynamic parameters
timeFrame: 48 hours
Secondary outcomes:
measure: clerance of cytokine
timeFrame: 48 hours
measure: clerance of cytokine
timeFrame: 48 hours
measure: clerance of cytokine
timeFrame: 48 hours
measure: clerance of cytokine
timeFrame: 48 hours
measure: Efficiency for middle molecules
timeFrame: 48 hours
measure: Efficiency for small molecules
timeFrame: 48 hours
measure: Efficiency for small molecules
timeFrame: 48 hours
measure: removal of antibiotics
timeFrame: 48 hours
measure: removal of antibiotics
timeFrame: 48 hours
measure: removal of antibiotics
timeFrame: 48 hours
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fiorenza Ferrari
state: PV
Study officials:
References: