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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: time span of filter change

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Zarbock, MD; Phone Number: +49-251-8347255; Email: zarbock@uni-muenster.de
• Study Contact Backup: Name: Nadja Schöne, MD; Phone Number: +49-8347262; Email: nadja.schoene@ukmuenster.de

Study Locations

• Germany
  • Münster, Germany, 48149
    • University Hospital Münster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early filter change; Scheduled filter change during continuous renal replacement therapy at 36 ± 3 hours.	Other: time span of filter change; The time span of the filter change during continuous renal replacement therapy will be specified
Active Comparator: Standard of Care filter change; Standard of care with scheduled filter change during continuous renal replacement therapy at 72 hours.	Other: time span of filter change; The time span of the filter change during continuous renal replacement therapy will be specified

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New intensive care unit-associated acquired infection up to day 30	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.	From start of CRRT to end of CRRT or at day 30 after randomization, whatever occurs first

Collaborators and Investigators

• Sponsor: Universität Münster
• Investigators: Study Chair: Alexander Zarbock, MD, University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Infection; critical illness; Continuous Renal Replacement Therapy (CRRT); filter change
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Critical Illness; Acute Kidney Injury; Infections
• Other Study ID Numbers: AnIt26-02; DRKS00039623 (Registry Identifier: Deutsches Register Klinischer Studien (DRKS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No