NCT07630220

Brief Summary

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.

Trial Health

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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

Study Progress2%
Jun 2026Jun 2028

First Submitted

Initial submission to the registry

June 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

June 5, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Continuous Renal Replacement Therapy (CRRT)Infectionfilter changecritical illness

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • New intensive care unit-associated acquired infection up to day 30

    From start of CRRT to end of CRRT or at day 30 after randomization, whatever occurs first

Study Arms (2)

Early filter change

EXPERIMENTAL

Scheduled filter change during continuous renal replacement therapy at 36 ± 3 hours.

Other: time span of filter change

Standard of Care filter change

ACTIVE COMPARATOR

Standard of care with scheduled filter change during continuous renal replacement therapy at 72 hours.

Other: time span of filter change

Interventions

The time span of the filter change during continuous renal replacement therapy will be specified

Early filter changeStandard of Care filter change

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult ≥ 18 years
  • Critically ill patients with severe AKI consistent with KDIGO stage 3 and an absolute indication for CRRT

You may not qualify if:

  • End-stage kidney disease or chronic dialysis dependence
  • Chronic kidney disease with eGFR\<20ml/min/1.73 m²
  • Prior kidney transplant
  • Prior renal replacement therapy during the index admission before randomization
  • Glomerulonephritis, interstitial nephritis, vasculitis
  • Patients on immunosuppression (above the cushing threshold)
  • Patients with chronic inflammatory diseases (e.g. arthritis, HIV with a CD4 count of \< 0.05 x 10E/l)
  • Do-not resuscitate order
  • Persons with any kind of dependency on the investigator or employed by the sponsor
  • Patients participating in an interventional study involving measures to influence the immune system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Münster

Münster, 48149, Germany

Location

Related Publications (2)

  • 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.

    PMID: 35549654BACKGROUND
  • 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.

    PMID: 33095849BACKGROUND

MeSH Terms

Conditions

Acute Kidney InjuryInfectionsCritical Illness

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Zarbock, MD

    University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy

    STUDY CHAIR

Central Study Contacts

Alexander Zarbock, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

June 5, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations