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Not yet recruiting NCT07630220

The Effect of Standard vs. Shorter Filter Lifespan During Continuous Renal Replacement Therapy

No phase Interventional Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: time span of filter change.
Who it may be relevant to
Registry conditions: Acute Kidney Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Standard vs. Shorter Filter Lifespan During Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury - a Feasibility Randomized Controlled Trial

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Mean filter lifespan per patient [Time frame: 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 [Time frame: From start of CRRT to end of CRRT or at day 30 after randomization, whatever occurs first]
Secondary outcome measures (1)
  • New intensive care unit (ICU)-associated acquired infection up to day 30 [Time frame: From start of CRRT to end of CRRT or at day 30 after randomization, whatever occurs first]

Eligibility criteria

Inclusion criteria

  • Adult ≥ 18 years
  • Critically ill patients with severe AKI consistent with KDIGO stage 3 and an absolute indication for CRRT
  • Written consent form from the patient or legal representative or authorized representative or emergency inclusion

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Germany · 1 center
  • University Hospital Münster — Münster

Publications

  • 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 PMID 35549654
  • 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 PMID 33095849

Identifiers

NCT: NCT07630220 · AnIt26-02 · DRKS00039623

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗