NCT05450185

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
3 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

March 2, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

2.2 years

First QC Date

July 5, 2022

Last Update Submit

December 6, 2024

Conditions

Critically IllContinuous Renal Replacement TherapyInfections

Outcome Measures

Primary Outcomes (1)

  • Number of new infections since start of dialysis

    From start of dialysis until day 28

Secondary Outcomes (23)

  • 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

    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

  • +18 more secondary outcomes

Other Outcomes (4)

  • Transmigration of neutrophils

    At initiation of dialysis

  • Transmigration of neutrophils

    24 hours after initiation of dialysis

  • Transmigration of neutrophils

    48 hours after initiation of dialysis

  • +1 more other outcomes

Interventions

Critically ill patients with continuous renal replacement therapyPROCEDURE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients

You may qualify if:

  • Adult patients (age ≥18 years)
  • Critically ill patients with dialysis-dependent AKI
  • Continuous renal replacement therapy (CRRT)
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Univ.-Klinik Innsbruck

Innsbruck, Austria

RECRUITING

Universidade de São Paulo

São Paulo, Brazil

RECRUITING

Universitätsklinikum Erlangen-Nürnberg, Abteilung für Nephrologie und Hypertensiologie

Erlangen, 91054, Germany

RECRUITING

Kliniken Maria Hilf, Klinik für Anästhesiologie und Operative Intensivmedizin

Mönchengladbach, 41063, Germany

RECRUITING

University Hospital Muenster

Münster, D-48149, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma, urine, dialysate

MeSH Terms

Conditions

Critical IllnessInfections

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Alexander Zarbock, MD

    University Hospital Münster

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Zarbock, MD

CONTACT

+49-251-8347252zarbock@uni-muenster.de

Melanie Meersch-Dini, MD

CONTACT

+49-251-47255

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 8, 2022

Study Start

March 2, 2023

Primary Completion

May 1, 2025

Study Completion

August 1, 2025

Last Updated

December 12, 2024

Record last verified: 2024-12

Locations

AU(1)BR(1)DE(3)