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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Critically ill patients with continuous renal replacement therapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of new infections since start of dialysis | From start of dialysis until day 28 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Transmigration of neutrophils | At initiation of dialysis | |
| Transmigration of neutrophils | 24 hours after initiation of dialysis | |
| Transmigration of neutrophils |
Inclusion Criteria:
Exclusion Criteria:
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Critically ill patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Zarbock, MD | Contact | +49-251-8347252 | zarbock@uni-muenster.de | |
| Melanie Meersch-Dini, MD | Contact | +49-251-47255 |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Zarbock, MD | University Hospital Münster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ.-Klinik Innsbruck | Recruiting | Innsbruck | Austria | |||
| Universidade de São Paulo |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D007239 | Infections |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000079664 | Continuous Renal Replacement Therapy |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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Blood plasma, urine, dialysate
| 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 |
| 48 hours after initiation of dialysis |
| Transmigration of neutrophils | 72 hours after initiation of dialysis |
| Recruiting |
| São Paulo |
| Brazil |
| Universitätsklinikum Erlangen-Nürnberg, Abteilung für Nephrologie und Hypertensiologie | Recruiting | Erlangen | 91054 | Germany |
| Kliniken Maria Hilf, Klinik für Anästhesiologie und Operative Intensivmedizin | Recruiting | Mönchengladbach | 41063 | Germany |
| University Hospital Muenster | Recruiting | Münster | D-48149 | Germany |
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