Filter Lifespan in Continuous Renal Replacement Therapy

Recruiting

• Conditions: Critically Ill; Infections; Continuous Renal Replacement Therapy

• Registration Number: NCT05450185
• Lead Sponsor: University Hospital Muenster

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-05
• Study First Posted: 2022-07-08
• Study Start: 2023-03-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-05
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of new infections since start of dialysis	From start of dialysis until day 28

Secondary Outcome Measures

Name	Time	Method
Number of new other infections	From start of dialysis until day 28
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
Duration of mechanical ventilation in hours	From start of dialysis until day 28
Filter live span	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
Number of new urinary tract infection	From start of dialysis until day 28
Number of bleeding complications	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	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	At day 90 after start of dialysis
Number of new blood stream infections	From start of dialysis until day 28
Number of new catheter blood stream infection	From start of dialysis until day 28
Mortality	At day 90 after start of dialysis
Number of new pneumonia	From start of dialysis until day 28
Days on renal replacement therapy	From start of dialysis until day 28
Major adverse kidney events (MAKE)	At day 90 after start of dialysis	Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction

Trial Locations

Locations (5)

Universitätsklinikum Erlangen-Nürnberg, Abteilung für Nephrologie und Hypertensiologie; 🇩🇪 Erlangen, Germany

Kliniken Maria Hilf, Klinik für Anästhesiologie und Operative Intensivmedizin; 🇩🇪 Mönchengladbach, Germany

Univ.-Klinik Innsbruck; 🇦🇹 Innsbruck, Austria

Universidade de São Paulo; 🇧🇷 São Paulo, Brazil

University Hospital Muenster; 🇩🇪 Muenster, Germany