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Filter Lifespan in Continuous Renal Replacement Therapy

NCT ID: NCT05450185

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-02

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Critically Ill Continuous Renal Replacement Therapy Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Zarbock, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Münster

Locations

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Univ.-Klinik Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

Universidade de São Paulo

São Paulo, , Brazil

Site Status RECRUITING

Universitätsklinikum Erlangen-Nürnberg, Abteilung für Nephrologie und Hypertensiologie

Erlangen, , Germany

Site Status RECRUITING

Kliniken Maria Hilf, Klinik für Anästhesiologie und Operative Intensivmedizin

Mönchengladbach, , Germany

Site Status RECRUITING

University Hospital Muenster

Münster, , Germany

Site Status RECRUITING

Countries

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Austria Brazil Germany

Central Contacts

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Alexander Zarbock, MD

Role: CONTACT

Phone: +49-251-8347252

Email: [email protected]

Melanie Meersch-Dini, MD

Role: CONTACT

Phone: +49-251-47255

Facility Contacts

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Zarbock

Role: primary

Other Identifiers

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10-AnIt-21

Identifier Type: -

Identifier Source: org_study_id