Clinical trial NCT05450185: Filter Lifespan in Continuous Renal Replacement Therapy
Official title: 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: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critically Ill
Continuous Renal Replacement Therapy
Infections
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2022-07-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of new infections since start of dialysis
timeFrame: From start of dialysis until day 28
Secondary outcomes:
measure: Number of new blood stream infections
timeFrame: From start of dialysis until day 28
measure: Number of new pneumonia
timeFrame: From start of dialysis until day 28
measure: Number of new urinary tract infection
timeFrame: From start of dialysis until day 28
measure: Number of new catheter blood stream infection
timeFrame: From start of dialysis until day 28
measure: Number of new other infections
timeFrame: From start of dialysis until day 28
measure: Filter live span
timeFrame: From start of dialysis until day 28 or end of CRRT, whatever occurs first
measure: Number of bacterial contamination of t he CRRT circuit proven by culture
timeFrame: From start of dialysis until day 28 or end of CRRT, whatever occurs first
measure: Down-time of CRRT in hours
timeFrame: From start of dialysis until day 28 or end of CRRT, whatever occurs first
measure: Days on renal replacement therapy
timeFrame: From start of dialysis until day 28
measure: Duration of mechanical ventilation in hours
timeFrame: From start of dialysis until day 28
measure: Number of bleeding complications
timeFrame: From start of dialysis until day 28
measure: Recovery of kidney function
timeFrame: At day 28 after start of dialysis
measure: Recovery of kidney function
timeFrame: At day 60 after start of dialysis
measure: Recovery of kidney function
timeFrame: At day 90 after start of dialysis
measure: Number of patients with need for kidney replacement therapy
timeFrame: At day 28 after start of dialysis
measure: Number of patients with need for kidney replacement therapy
timeFrame: At day 60 after start of dialysis
measure: Number of patients with need for kidney replacement therapy
timeFrame: At day 90 after start of dialysis
measure: Mortality
timeFrame: At day 28 after start of dialysis
measure: Mortality
timeFrame: At day 60 after start of dialysis
measure: Mortality
timeFrame: At day 90 after start of dialysis
measure: Major adverse kidney events (MAKE)
timeFrame: At day 28 after start of dialysis
measure: Major adverse kidney events (MAKE)
timeFrame: At day 60 after start of dialysis
measure: Major adverse kidney events (MAKE)
timeFrame: At day 90 after start of dialysis
Other outcomes:
measure: Transmigration of neutrophils
timeFrame: At initiation of dialysis
measure: Transmigration of neutrophils
timeFrame: 24 hours after initiation of dialysis
measure: Transmigration of neutrophils
timeFrame: 48 hours after initiation of dialysis
measure: Transmigration of neutrophils
timeFrame: 72 hours after initiation of dialysis
Locations:
city: Innsbruck
country: Austria
facility: Univ.-Klinik Innsbruck
city: São Paulo
country: Brazil
facility: Universidade de São Paulo
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen-Nürnberg, Abteilung für Nephrologie und Hypertensiologie
city: Muenster
country: Germany
facility: University Hospital Muenster
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf, Klinik für Anästhesiologie und Operative Intensivmedizin
Study officials:
affiliation: University Hospital Münster
name: Alexander Zarbock, MD
role: PRINCIPAL_INVESTIGATOR
References: