Critically IllCRRTInfONCT05450185
Filter Lifespan in Continuous Renal Replacement Therapy
An observational study of Critically Ill and Continuous Renal Replacement Therapy, run by University Hospital Muenster at 5 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Continuous Renal Replacement Therapy, Infections
- What is being tested?
- Critically ill patients with continuous renal replacement therapy
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 2 Mar 2023to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients
Who may be able to join
- Adult patients (age ≥18 years)
- Critically ill patients with dialysis-dependent AKI
- Continuous renal replacement therapy (CRRT)
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Melanie Meersch-Dini, MD contact
5 sites in 3 countries
Germany3 sites, 3 recruiting
- Recruiting
Universitätsklinikum Erlangen-Nürnberg, Abteilung für Nephrologie und Hypertensiologie
Erlangen, 91054
- Recruiting
Kliniken Maria Hilf, Klinik für Anästhesiologie und Operative Intensivmedizin
Mönchengladbach, 41063
- Recruiting
University Hospital Muenster
Münster, D-48149
Zarbock, aki@uni-muenster.de
About this study
Official title: The Effect of Filter Lifespan in Continuous Renal Replacement Therapy on the Rate of New Infections in Critically Ill Patients: a Prospective, Multicenter, Observational Trial
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.
Read the detailed description
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.
- Being tested
- Critically ill patients with continuous renal replacement therapy
- Medical subject headings
- Critical Illness, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critically ill patients with continuous renal replacement therapyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new infections since start of dialysis
Measured: From start of dialysis until day 28
Secondary outcomes (23)
Number of new blood stream infections
Measured: From start of dialysis until day 28
Number of new pneumonia
Measured: From start of dialysis until day 28
Number of new urinary tract infection
Measured: From start of dialysis until day 28
Number of new catheter blood stream infection
Measured: From start of dialysis until day 28
Number of new other infections
Measured: From start of dialysis until day 28
Filter live span
Measured: From start of dialysis until day 28 or end of CRRT, whatever occurs first
Number of bacterial contamination of t he CRRT circuit proven by culture
Measured: From start of dialysis until day 28 or end of CRRT, whatever occurs first
Down-time of CRRT in hours
Measured: From start of dialysis until day 28 or end of CRRT, whatever occurs first
Days on renal replacement therapy
Measured: From start of dialysis until day 28
Duration of mechanical ventilation in hours
Measured: From start of dialysis until day 28
Number of bleeding complications
defined as bleeding with the need for at least 1 packed red cells (RBC)
Measured: From start of dialysis until day 28
Recovery of kidney function
Recovery of kidney function (defined as complete recovery: serum-creatinine ≤0.5 mg/dl higher than baseline; partial recovery: serum creatinine >0.5 mg/dl higher than baseline but no dialysis-dependence; non-recovery: patients who remained dialysis-dependent)
Measured: At day 28 after start of dialysis
Recovery of kidney function
Recovery of kidney function (defined as complete recovery: serum-creatinine ≤0.5 mg/dl higher than baseline; partial recovery: serum creatinine >0.5 mg/dl higher than baseline but no dialysis-dependence; non-recovery: patients who remained dialysis-dependent)
Measured: At day 60 after start of dialysis
Recovery of kidney function
Recovery of kidney function (defined as complete recovery: serum-creatinine ≤0.5 mg/dl higher than baseline; partial recovery: serum creatinine >0.5 mg/dl higher than baseline but no dialysis-dependence; non-recovery: patients who remained dialysis-dependent)
Measured: At day 90 after start of dialysis
Number of patients with need for kidney replacement therapy
Measured: At day 28 after start of dialysis
Number of patients with need for kidney replacement therapy
Measured: At day 60 after start of dialysis
Number of patients with need for kidney replacement therapy
Measured: At day 90 after start of dialysis
Mortality
Measured: At day 28 after start of dialysis
Mortality
Measured: At day 60 after start of dialysis
Mortality
Measured: At day 90 after start of dialysis
Major adverse kidney events (MAKE)
Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction
Measured: At day 28 after start of dialysis
Major adverse kidney events (MAKE)
Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction
Measured: At day 60 after start of dialysis
Major adverse kidney events (MAKE)
Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction
Measured: At day 90 after start of dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start2 Mar 2023
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Alexander Zarbock, MD, Principal investigator, University Hospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450185
- Sponsor's protocol ID
- 10-AnIt-21
- Acronym
- CRRTInfO
- Status last verified
- Dec 2024
- First submitted
- 5 Jul 2022
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Filter Lifespan in Continuous Renal Replacement Therapy on the Rate of New Infections in Critically Ill Patients: a Prospective, Multicenter, Observational Trial
- ClinicalTrials.gov ID
- NCT05450185
- Acronym / sponsor ID
- CRRTInfO / 10-AnIt-21
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients
Key inclusion criteria (4 listed)
- Adult patients (age ≥18 years)
- Critically ill patients with dialysis-dependent AKI
- Continuous renal replacement therapy (CRRT)
- Written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critically ill patients with continuous renal replacement therapyDue 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. | Procedure or surgery | – |
Primary outcome
Number of new infections since start of dialysis
Time frame: From start of dialysis until day 28
23 secondary outcomes
Number of new blood stream infections
Time frame: From start of dialysis until day 28
Number of new pneumonia
Time frame: From start of dialysis until day 28
Number of new urinary tract infection
Time frame: From start of dialysis until day 28
Number of new catheter blood stream infection
Time frame: From start of dialysis until day 28
Number of new other infections
Time frame: From start of dialysis until day 28
Filter live span
Time frame: From start of dialysis until day 28 or end of CRRT, whatever occurs first
Number of bacterial contamination of t he CRRT circuit proven by culture
Time frame: From start of dialysis until day 28 or end of CRRT, whatever occurs first
Down-time of CRRT in hours
Time frame: From start of dialysis until day 28 or end of CRRT, whatever occurs first
Days on renal replacement therapy
Time frame: From start of dialysis until day 28
Duration of mechanical ventilation in hours
Time frame: From start of dialysis until day 28
Number of bleeding complications
Time frame: From start of dialysis until day 28
Recovery of kidney function
Time frame: At day 28 after start of dialysis
Recovery of kidney function
Time frame: At day 60 after start of dialysis
Recovery of kidney function
Time frame: At day 90 after start of dialysis
Number of patients with need for kidney replacement therapy
Time frame: At day 28 after start of dialysis
Number of patients with need for kidney replacement therapy
Time frame: At day 60 after start of dialysis
Number of patients with need for kidney replacement therapy
Time frame: At day 90 after start of dialysis
Mortality
Time frame: At day 28 after start of dialysis
Mortality
Time frame: At day 60 after start of dialysis
Mortality
Time frame: At day 90 after start of dialysis
Major adverse kidney events (MAKE)
Time frame: At day 28 after start of dialysis
Major adverse kidney events (MAKE)
Time frame: At day 60 after start of dialysis
Major adverse kidney events (MAKE)
Time frame: At day 90 after start of dialysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melanie Meersch-Dini, MD contact
Alexander Zarbock, MD principal investigator
University Hospital Münster
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Continuous Renal Replacement Therapy, run by University Hospital Muenster at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Austria, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Zarbock, MD (+49-251-8347252, zarbock@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of new infections since start of dialysis (time frame: From start of dialysis until day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.