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

Overview

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.

Full Title of Study: “Clearance of Inflammatory Cytokines in Patients With Septic Acute Kidney Injury During Renal Replacement Therapy Using the EMIC®2 Filter”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 1, 2018

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.

Clinical Trial Outcome Measures

Primary Measures

  • Removal of inflammatory mediators
    • Time Frame: 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 Measures

  • Adsorption of inflammatory mediators
    • Time Frame: 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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guy’s and St Thomas’ NHS Foundation Trust
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marlies Ostermann, PhD, Study Director, Guy’s & St Thomas Hospital London

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.