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

Acute Renal Failure Clinical Trial

— ClicAKI  

Official title:

Clearance of Inflammatory Cytokines in Patients With Septic Acute Kidney Injury During Renal Replacement Therapy Using the EMIC®2 Filter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231748
• Other study ID #: IRAS ID: 196972
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: October 2019
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-a), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor	48 hours
Secondary	Adsorption of inflammatory mediators	Adsorption of IL-1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-a), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor	48 hours