Filter Lifespan in Continuous Renal Replacement Therapy

Critically Ill Clinical Trial

— CRRTInfO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05450185
• Other study ID #: 10-AnIt-21
• Status: Recruiting
• Start date: March 2, 2023
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: University Hospital Muenster
• Contact: Alexander Zarbock, MD
• Phone: +49-251-8347252
• Email: zarbock[@]uni-muenster.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Continuous Renal Replacement Therapy
• Critical Illness
• Critically Ill
• Infections

Intervention

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.

Locations

Country	Name	City	State
Austria	Univ.-Klinik Innsbruck	Innsbruck
Brazil	Universidade de São Paulo	São Paulo
Germany	University Hospital Muenster	Muenster

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Baxter Healthcare Corporation

Countries where clinical trial is conducted

Austria,  Brazil,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Transmigration of neutrophils		At initiation of dialysis
Other	Transmigration of neutrophils		24 hours after initiation of dialysis
Other	Transmigration of neutrophils		48 hours after initiation of dialysis
Other	Transmigration of neutrophils		72 hours after initiation of dialysis
Primary	Number of new infections since start of dialysis		From start of dialysis until day 28
Secondary	Number of new blood stream infections		From start of dialysis until day 28
Secondary	Number of new pneumonia		From start of dialysis until day 28
Secondary	Number of new urinary tract infection		From start of dialysis until day 28
Secondary	Number of new catheter blood stream infection		From start of dialysis until day 28
Secondary	Number of new other infections		From start of dialysis until day 28
Secondary	Filter live span		From start of dialysis until day 28 or end of CRRT, whatever occurs first
Secondary	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
Secondary	Down-time of CRRT in hours		From start of dialysis until day 28 or end of CRRT, whatever occurs first
Secondary	Days on renal replacement therapy		From start of dialysis until day 28
Secondary	Duration of mechanical ventilation in hours		From start of dialysis until day 28
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients with need for kidney replacement therapy		At day 28 after start of dialysis
Secondary	Number of patients with need for kidney replacement therapy		At day 60 after start of dialysis
Secondary	Number of patients with need for kidney replacement therapy		At day 90 after start of dialysis
Secondary	Mortality		At day 28 after start of dialysis
Secondary	Mortality		At day 60 after start of dialysis
Secondary	Mortality		At day 90 after start of dialysis
Secondary	Major adverse kidney events (MAKE)	Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction	At day 28 after start of dialysis
Secondary	Major adverse kidney events (MAKE)	Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction	At day 60 after start of dialysis
Secondary	Major adverse kidney events (MAKE)	Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction	At day 90 after start of dialysis