NCT01067313

Brief Summary

This study aims to demonstrate equivalence in terms of molecule removal between continuous hemodialysis using an "enhanced middle molecule clearance" membrane(Ultraflux EMiC2) and continuous hemofiltration using a standard membrane (Ultraflux AV1000S) in ICU patients requiring continuous renal replacement therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2008

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

July 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 29, 2011

Status Verified

February 1, 2010

Enrollment Period

2 years

First QC Date

February 10, 2010

Last Update Submit

March 28, 2011

Conditions

Septic Shock

Keywords

Intensive Care Unitcontinuous hemodialysiscontinuous hemofiltrationHigh Cut-off membrane"Enhanced middle molecule clearance" membraneSeptic shockAcute kidney injuryBlood purificationRenal replacement therapy

Outcome Measures

Primary Outcomes (6)

  • Clearance of Urea

    At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  • Clearance of creatinine

    At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  • Clearance of total protein

    At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  • Clearance of albumin

    At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  • Clearance of Beta 2-microglobulin

    At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  • Free light chains kappa of Immunoglobulins

    At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

Secondary Outcomes (5)

  • Mean arterial pressure

    Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  • vasopressor requirement

    Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  • PaO2 / FiO2

    Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  • Heart rate

    Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  • Lactate level

    Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

Study Arms (2)

Dialyzer Ultraflux EMiC2

EXPERIMENTAL

Dialyzer Ultraflux EMiC2 used in Continuous Hemodialysis

Device: Dialyzer Ultraflux EMiC2

Dialyzer Ultraflux AV1000S

ACTIVE COMPARATOR

Dialyzer Ultraflux AV1000S used in continuous Hemofiltration

Device: Dialyzer Ultraflux AV1000S

Interventions

Dialyzer Ultraflux EMiC2DEVICE

Dialysate flow rate = 40 ml/kg/h The treatment duration may be variable depending on modifications in patient health status, but will not exceed 3 sessions of 48 hours each.

Dialyzer Ultraflux EMiC2
Dialyzer Ultraflux AV1000SDEVICE

Ultrafiltration flow rate = 40 ml/kg/h The blood flow rate will be adjusted to obtain a filtration fraction of 20%. Reinjection = 100% postdilution. The treatment duration may be variable depending on modifications in patient health status, but will not exceed 3 sessions of 48 hours each.

Dialyzer Ultraflux AV1000S

Eligibility Criteria

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

You may qualify if:

  • Male or female aged over 18 years.
  • ICU patients with septic shock and AKI requiring continuous renal replacement.
  • Patient able to agree to be enrolled in the study with informed consent. If the patient can not provide consent, only the consent of family members will be sought if they are present and, to default, the opinion of trustworthy person under article L.1111-6 of the French Health Code. If there is no family present, or trustworthy person designated, the subject will not be included in the study.

You may not qualify if:

  • Pregnancy or lactation.
  • Participation in another research protocol.
  • People particularly vulnerable as defined in Articles L.1121-5, L.1121-6, L.1121-7, L.1121-8 et L.1122-1-2 of the French Health Code.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edouard Herriot Hospital, P Reanimation

Lyon, 69003, France

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 Officials

  • Bernard Allaouchiche, Professor

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 10, 2010

First Posted

February 11, 2010

Study Start

July 1, 2008

Primary Completion

July 1, 2010

Study Completion

January 1, 2011

Last Updated

March 29, 2011

Record last verified: 2010-02

Locations

FR(1)