Continuous Renal Replacement Therapy, Critically Ill, Infections
Conditions
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.
Interventions
PROCEDURECritically 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.
Sponsors
Baxter Healthcare Corporation
University Hospital Muenster
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of new infections since start of dialysis | From start of dialysis until day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 new blood stream infections | From start of dialysis until day 28 | — |
| Number of new pneumonia | From start of dialysis until day 28 | — |
| 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 | 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 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) |
| Number of patients with need for kidney replacement therapy | At day 28 after start of dialysis | — |
| Mortality | At day 28 after start of dialysis | — |
| Major adverse kidney events (MAKE) | At day 28 after start of dialysis | Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction |
| 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 | — |
Other
| Measure | Time frame |
|---|---|
| Transmigration of neutrophils | At initiation of dialysis |
Countries
Austria, Brazil, Germany
Contacts
Primary ContactAlexander Zarbock, MD
Backup ContactMelanie Meersch-Dini, MD
Outcome results
None listed