NCT03231748

Brief Summary

This study will be conducted in patients with sepsis and acute kidney injury needing renal replacement therapy. The aim is to investigate whether continuous renal replacement therapy with the EMIC®2 filter leads to removal of pro-inflammatory middle molecular weight cytokines from the blood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

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, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

July 10, 2017

Last Update Submit

October 21, 2019

Conditions

Acute Renal Failure

Outcome Measures

Primary Outcomes (1)

  • Removal of inflammatory mediators

    Clearance of the following mediators Interleukin (IL) -1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor

    48 hours

Secondary Outcomes (1)

  • Adsorption of inflammatory mediators

    48 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with sepsis and acute kidney injury who require renal replacement therapy.

You may qualify if:

  • adult patients (≥18 years) in the Critical Care Unit with AKI and sepsis
  • clinical decision that citrate based continuous veno-venous haemodialysis (CVVHD) is necessary

You may not qualify if:

  • lack of consent
  • pre-existing dialysis dependent renal failure
  • life expectancy \<24 hours
  • patients with haemoglobin \<7g/dL (unless transfused for clinical reasons)
  • need for extracorporeal membrane oxygenation (ECMO)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's & St Thomas Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

  • Lumlertgul N, Hall A, Camporota L, Crichton S, Ostermann M. Clearance of inflammatory cytokines in patients with septic acute kidney injury during renal replacement therapy using the EMiC2 filter (Clic-AKI study). Crit Care. 2021 Jan 28;25(1):39. doi: 10.1186/s13054-021-03476-x.

    PMID: 33509215DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Marlies Ostermann, PhD

    Guy's & St Thomas Hospital London

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 27, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

October 23, 2019

Record last verified: 2019-10

Locations

GB(1)