Filter Lifespan in Continuous Renal Replacement Therapy (CRRTInfO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infections; Critically Ill; Continuous Renal Replacement Therapy
• Intervention / Treatment: Procedure: Critically ill patients with continuous renal replacement therapy

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Alexander Zarbock, MD; Phone Number: +49-251-8347252; Email: zarbock@uni-muenster.de
• Study Contact Backup: Name: Melanie Meersch-Dini, MD; Phone Number: +49-251-47255

Study Locations

• Austria
  • Innsbruck, Austria
    • Recruiting
    • Univ.-Klinik Innsbruck
• Brazil
  • São Paulo, Brazil
    • Recruiting
    • Universidade de São Paulo
• Germany
  • Erlangen, Germany, 91054
    • Recruiting
    • Universitätsklinikum Erlangen-Nürnberg, Abteilung für Nephrologie und Hypertensiologie
  • Muenster, Germany, D-48149
    • Recruiting
    • University hospital Muenster
    • Contact: Zarbock; Email: aki@uni-muenster.de
  • Mönchengladbach, Germany, 41063
    • Recruiting
    • Kliniken Maria Hilf, Klinik für Anästhesiologie und Operative Intensivmedizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Critically ill patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of new infections since start of dialysis	From start of dialysis until day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of new blood stream infections		From start of dialysis until day 28
Number of new pneumonia		From start of dialysis until day 28
Number of new urinary tract infection		From start of dialysis until day 28
Number of new catheter blood stream infection		From start of dialysis until day 28
Number of new other infections		From start of dialysis until day 28
Filter live span		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		From start of dialysis until day 28 or end of CRRT, whatever occurs first
Down-time of CRRT in hours		From start of dialysis until day 28 or end of CRRT, whatever occurs first
Days on renal replacement therapy		From start of dialysis until day 28
Duration of mechanical ventilation in hours		From start of dialysis until day 28
Number of bleeding complications	defined as bleeding with the need for at least 1 packed red cells (RBC)	From start of dialysis until day 28
Recovery of kidney function	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)	At day 28 after start of dialysis
Recovery of kidney function	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)	At day 60 after start of dialysis
Recovery of kidney function	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)	At day 90 after start of dialysis
Number of patients with need for kidney replacement therapy		At day 28 after start of dialysis
Number of patients with need for kidney replacement therapy		At day 60 after start of dialysis
Number of patients with need for kidney replacement therapy		At day 90 after start of dialysis
Mortality		At day 28 after start of dialysis
Mortality		At day 60 after start of dialysis
Mortality		At day 90 after start of dialysis
Major adverse kidney events (MAKE)	Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction	At day 28 after start of dialysis
Major adverse kidney events (MAKE)	Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction	At day 60 after start of dialysis
Major adverse kidney events (MAKE)	Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction	At day 90 after start of dialysis

Other Outcome Measures

Outcome Measure	Time Frame
Transmigration of neutrophils	At initiation of dialysis
Transmigration of neutrophils	24 hours after initiation of dialysis
Transmigration of neutrophils	48 hours after initiation of dialysis
Transmigration of neutrophils	72 hours after initiation of dialysis

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Alexander Zarbock, MD, University Hospital Münster

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Infections
• Other Study ID Numbers: 10-AnIt-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No