MCO Membrane Efficiency in Septic Shock Patients

NCT ID: NCT04834921

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-31
• Study Completion Date: 2021-01-31

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.

Conditions

Septic Shock; Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

MCO-CVVHD

CVVHD with MCO filter for 24 hours

Group Type: EXPERIMENTAL

Ultraflux® EMiC®2

Intervention Type: 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

HFF-CVVHDF

CVVHDF with high flux filter for 24 hours

Group Type: ACTIVE_COMPARATOR

Ultraflux® EMiC®2

Intervention Type: 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

Interventions

Ultraflux® EMiC®2

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

Intervention Type: DEVICE

Other Intervention Names

HFF-CVVHDF

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Renal Research Institute Vicenza

OTHER

Sponsor Role: collaborator

University of Giessen

OTHER

Sponsor Role: collaborator

Fiorenza Ferrari

OTHER

Sponsor Role: lead

Responsible Party

Fiorenza Ferrari

Senior Consultant at intensive Care Unit of Hospital San Matteo, Pavoa, Italy

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Fiorenza Ferrari

Pavia, PV, Italy

Countries

Italy

Other Identifiers

46/15A

Identifier Type: -

Identifier Source: org_study_id