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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00039623 | Registry Identifier | Deutsches Register Klinischer Studien (DRKS) |
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This study aims to investigate shorter vs. standard filter lifespans in critically ill patients receiving continuous renal replacement therapy (CRRT) for acute kidney injury (AKI). The aim of this trial is to reliably implement,scheduled filter changes and to investigate whether shorter filter lifetime is associated with a lower incidence in rate of new infections.
Own data of patients under standard care indicated that a longer filter lifetime in CRRT is associated with an increased rate of new infections.
The aim of this study is to demonstrate that a protocolized filter-change strategy can be reliably implemented in critically ill patients and a high protocol adherence can be achieved.
The secondary aim is to investigate whether a shorter filter-change strategy is be associated with a lower incidence of newly acquired infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early filter change | Experimental | Scheduled filter change during continuous renal replacement therapy at 36 ± 3 hours. |
|
| Standard of Care filter change | Active Comparator | Standard of care with scheduled filter change during continuous renal replacement therapy at 72 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| time span of filter change | Other | The time span of the filter change during continuous renal replacement therapy will be specified |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean filter lifespan per patient | Comparison of mean filter lifespans between study groups | From start of CRRT to end of CRRT or at day 30 after randomization, whatever occurs first |
| Protocol adherence as documented filter change within the specified period | Proportion of protocol adherent patients, defined as patients with mean filter lifespan within the pre-specified time window in each arm (intervention group: 36±3hours; control group: 48-72hours | From start of CRRT to end of CRRT or at day 30 after randomization, whatever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| New intensive care unit (ICU)-associated acquired infection up to day 30 | Rate of new ICU-acquired infections, defined as new infection in patients with pre-existing infection but with another pathogen than baseline or without baseline infection. All infections need to be culture proven. Only the first infection per patient will be considered | From start of CRRT to end of CRRT or at day 30 after randomization, whatever occurs first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Zarbock, MD | Contact | +49-251-8347255 | zarbock@uni-muenster.de | |
| Nadja Schöne, MD | Contact | +49-8347262 | nadja.schoene@ukmuenster.de |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Zarbock, MD | University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Münster | Münster | 48149 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35549654 | Background | Gerss J, Meersch M, Kindgen-Milles D, Brandenburger T, Willam C, Kellum JA, Zarbock A. The Effect of Filter Lifespan during Continuous Renal Replacement Therapy in Critically Ill Patients with Acute Kidney Injury on the Rate of New-Onset Infection: Analysis from the RICH Randomized Controlled Trial. Am J Respir Crit Care Med. 2022 Aug 15;206(4):511-514. doi: 10.1164/rccm.202201-0063LE. No abstract available. | |
| 33095849 |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D007239 | Infections |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Background |
| Zarbock A, Kullmar M, Kindgen-Milles D, Wempe C, Gerss J, Brandenburger T, Dimski T, Tyczynski B, Jahn M, Mulling N, Mehrlander M, Rosenberger P, Marx G, Simon TP, Jaschinski U, Deetjen P, Putensen C, Schewe JC, Kluge S, Jarczak D, Slowinski T, Bodenstein M, Meybohm P, Wirtz S, Moerer O, Kortgen A, Simon P, Bagshaw SM, Kellum JA, Meersch M; RICH Investigators and the Sepnet Trial Group. Effect of Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation During Continuous Kidney Replacement Therapy on Dialysis Filter Life Span and Mortality Among Critically Ill Patients With Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2020 Oct 27;324(16):1629-1639. doi: 10.1001/jama.2020.18618. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |