Clearance of Inflammatory Cytokines During Renal Replacement Therapy Using the EMIC®2 Filter

NCT ID: NCT03231748

Last Updated: 2019-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-07-01

Brief Summary

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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.

Detailed Description

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In patients with acute kidney injury (AKI) and sepsis requiring renal replacement therapy, the investigators aim to determine whether continuous veno-venous haemodialysis with an EMiC®2 filter leads to 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.

Conditions

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Acute Renal Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marlies Ostermann, PhD

Role: STUDY_DIRECTOR

Guy's & St Thomas Hospital London

Locations

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Guy's & St Thomas Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 33509215 (View on PubMed)

Other Identifiers

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IRAS ID: 196972

Identifier Type: -

Identifier Source: org_study_id

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