NCT04834921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
Last Updated

April 12, 2021

Status Verified

April 1, 2021

Enrollment Period

2.1 years

First QC Date

March 30, 2021

Last Update Submit

April 7, 2021

Conditions

Septic ShockAcute Kidney Injury

Keywords

Renal Replacement Therapy,CytokinesEfficiency

Outcome Measures

Primary Outcomes (9)

  • improvement in haemodynamic parameters

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

    48 hours

  • improvement in haemodynamic parameters

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

    48 hours

  • improvement in haemodynamic parameters

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

    48 hours

  • improvement in haemodynamic parameters

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

    48 hours

  • improvement in haemodynamic parameters

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

    48 hours

  • improvement in haemodynamic parameters

    measurements of the hemodynamic parameters: PVC (mmHg)

    48 hours

  • improvement in haemodynamic parameters

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

    48 hours

  • improvement in haemodynamic parameters

    measurements of the hemodynamic parameters: SCVO2 (%)

    48 hours

  • improvement in haemodynamic parameters

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

    48 hours

Secondary Outcomes (10)

  • clerance of cytokine

    48 hours

  • clerance of cytokine

    48 hours

  • clerance of cytokine

    48 hours

  • clerance of cytokine

    48 hours

  • Efficiency for middle molecules

    48 hours

  • +5 more secondary outcomes

Study Arms (2)

MCO-CVVHD

EXPERIMENTAL

CVVHD with MCO filter for 24 hours

Device: Ultraflux® EMiC®2

HFF-CVVHDF

ACTIVE COMPARATOR

CVVHDF with high flux filter for 24 hours

Device: Ultraflux® EMiC®2

Interventions

Ultraflux® EMiC®2DEVICE

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

Also known as: HFF-CVVHDF
HFF-CVVHDFMCO-CVVHD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fiorenza Ferrari

Pavia, PV, 27000, Italy

Location

MeSH Terms

Conditions

Shock, SepticAcute Kidney Injury

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Blinding procedure was limited to the doctors who collected the data and the external statistician who performed the analysis
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Consultant at intensive Care Unit of Hospital San Matteo, Pavoa, Italy

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 8, 2021

Study Start

December 31, 2017

Primary Completion

February 21, 2020

Study Completion

January 31, 2021

Last Updated

April 12, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)