Filter Lifespan in Continuous Renal Replacement Therapy

Overview

The only supportive therapy for patients with AKI is renal replacement therapy (RRT). In the ICU setting, continuous RRT (CRRT) is mostly favored. In a post-hoc analysis of the RICH trial (regional citrate versus systemic heparin anticoagulation for CRRT in critically ill patient with AKI), it was shown that the filter life span is associated with an increased rate of new infection and that the type of anticoagulants did not directly affect infection rate. The mechanisms of this infection rate is unknown.

Full Title of Study: “The Effect of Filter Lifespan in Continuous Renal Replacement Therapy on the Rate of New Infections in Critically Ill Patients: a Prospective, Multicenter, Observational Trial”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2024

Detailed Description

Approximately every second patient in the ICU suffers from acute kidney injury (AKI) which complicates the clinical course of these patients. Continuous renal replacement therapy (CRRT) has become the most widely used form of renal support in critically ill patients as it allows continuous, controlled removal of fluids and is hemodynamically better tolerated compared to intermittent dialysis. The requirement for intravascular access and artificial circuits may increase the risk of infection. However, there are no studies analyzing the incidence and characteristics of infections in critically ill patients with CRRT or the implications for outcome. Therefore, this observational trial investigates the factors that influences new onset infection in critically ill patients with CRRT.

Interventions

  • Procedure: Critically ill patients with continuous renal replacement therapy
    • Due to the observational design of the study, no study-specific interventions are performed. The treatment of the patients is completely guided by the responsible ICU physicians.

Clinical Trial Outcome Measures

Primary Measures

  • Number of new infections since start of dialysis
    • Time Frame: From start of dialysis until day 28

Secondary Measures

  • Number of new blood stream infections
    • Time Frame: From start of dialysis until day 28
  • Number of new pneumonia
    • Time Frame: From start of dialysis until day 28
  • Number of new urinary tract infection
    • Time Frame: From start of dialysis until day 28
  • Number of new catheter blood stream infection
    • Time Frame: From start of dialysis until day 28
  • Number of new other infections
    • Time Frame: From start of dialysis until day 28
  • Filter live span
    • Time Frame: From start of dialysis until day 28 or end of CRRT, whatever occurs first
  • Number of bacterial contamination of t he CRRT circuit proven by culture
    • Time Frame: From start of dialysis until day 28 or end of CRRT, whatever occurs first
  • Down-time of CRRT in hours
    • Time Frame: From start of dialysis until day 28 or end of CRRT, whatever occurs first
  • Days on renal replacement therapy
    • Time Frame: From start of dialysis until day 28
  • Duration of mechanical ventilation in hours
    • Time Frame: From start of dialysis until day 28
  • Number of bleeding complications
    • Time Frame: From start of dialysis until day 28
    • defined as bleeding with the need for at least 1 packed red cells (RBC)
  • Recovery of kidney function
    • Time Frame: At day 28 after start of dialysis
    • Recovery of kidney function (defined as complete recovery: serum-creatinine ≤0.5 mg/dl higher than baseline; partial recovery: serum creatinine >0.5 mg/dl higher than baseline but no dialysis-dependence; non-recovery: patients who remained dialysis-dependent)
  • Recovery of kidney function
    • Time Frame: At day 60 after start of dialysis
    • Recovery of kidney function (defined as complete recovery: serum-creatinine ≤0.5 mg/dl higher than baseline; partial recovery: serum creatinine >0.5 mg/dl higher than baseline but no dialysis-dependence; non-recovery: patients who remained dialysis-dependent)
  • Recovery of kidney function
    • Time Frame: At day 90 after start of dialysis
    • Recovery of kidney function (defined as complete recovery: serum-creatinine ≤0.5 mg/dl higher than baseline; partial recovery: serum creatinine >0.5 mg/dl higher than baseline but no dialysis-dependence; non-recovery: patients who remained dialysis-dependent)
  • Number of patients with need for kidney replacement therapy
    • Time Frame: At day 28 after start of dialysis
  • Number of patients with need for kidney replacement therapy
    • Time Frame: At day 60 after start of dialysis
  • Number of patients with need for kidney replacement therapy
    • Time Frame: At day 90 after start of dialysis
  • Mortality
    • Time Frame: At day 28 after start of dialysis
  • Mortality
    • Time Frame: At day 60 after start of dialysis
  • Mortality
    • Time Frame: At day 90 after start of dialysis
  • Major adverse kidney events (MAKE)
    • Time Frame: At day 28 after start of dialysis
    • Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction
  • Major adverse kidney events (MAKE)
    • Time Frame: At day 60 after start of dialysis
    • Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction
  • Major adverse kidney events (MAKE)
    • Time Frame: At day 90 after start of dialysis
    • Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients (age ≥18 years) – Critically ill patients with dialysis-dependent AKI – Continuous renal replacement therapy (CRRT) – Written informed consent Exclusion Criteria:

  • Chronic kidney disease with estimated glomerular filtration rate (eGFR)<30ml/min/1.73m2 – Chronic dialysis dependency – Kidney transplant – (Glomerulo-)nephritis, interstitial nephritis, vasculitis – Patients on immunosuppression – Patients with chronic inflammatory diseases (e.g. arthritis, HIV, chronic hepatitis) – Persons with any kind of dependency on the investigator or employed by the sponsor or investigator

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Muenster
  • Collaborator
    • Baxter Healthcare Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alexander Zarbock, MD, Principal Investigator, University Hospital Münster
  • Overall Contact(s)
    • Alexander Zarbock, MD, +49-251-8347252, zarbock@uni-muenster.de

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