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

Completed

• Conditions: Acute Renal Failure

• Registration Number: NCT03231748
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-27
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Removal of inflammatory mediators	48 hours	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

Secondary Outcome Measures

Name	Time	Method
Adsorption of inflammatory mediators	48 hours	Adsorption of 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

Trial Locations

Locations (1)

Guy's & St Thomas Hospital; 🇬🇧 London, United Kingdom