Filter Lifespan in Continuous Renal Replacement Therapy (CRRTInfO)

December 6, 2024 updated by: University Hospital Muenster

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Melanie Meersch-Dini, MD
  • Phone Number: +49-251-47255

Study Locations

  • Austria
      • Innsbruck, Austria
        • Recruiting
        • Univ.-Klinik Innsbruck
  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Universidade de São Paulo
  • Germany
      • Erlangen, Germany, 91054
        • Recruiting
        • Universitätsklinikum Erlangen-Nürnberg, Abteilung für Nephrologie und Hypertensiologie
      • Muenster, Germany, D-48149
      • Mönchengladbach, Germany, 41063
        • Recruiting
        • Kliniken Maria Hilf, Klinik für Anästhesiologie und Operative Intensivmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Critically ill patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of new infections since start of dialysis
Time Frame: From start of dialysis until day 28
From start of dialysis until day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of new blood stream infections
Time Frame: From start of dialysis until day 28
From start of dialysis until day 28
Number of new pneumonia
Time Frame: From start of dialysis until day 28
From start of dialysis until day 28
Number of new urinary tract infection
Time Frame: From start of dialysis until day 28
From start of dialysis until day 28
Number of new catheter blood stream infection
Time Frame: From start of dialysis until day 28
From start of dialysis until day 28
Number of new other infections
Time Frame: From start of dialysis until day 28
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
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
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
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
From start of dialysis until day 28
Duration of mechanical ventilation in hours
Time Frame: From start of dialysis until day 28
From start of dialysis until day 28
Number of bleeding complications
Time Frame: From start of dialysis until day 28
defined as bleeding with the need for at least 1 packed red cells (RBC)
From start of dialysis until day 28
Recovery of kidney function
Time Frame: At day 28 after start of dialysis
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)
At day 28 after start of dialysis
Recovery of kidney function
Time Frame: At day 60 after start of dialysis
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)
At day 60 after start of dialysis
Recovery of kidney function
Time Frame: At day 90 after start of dialysis
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)
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
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
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
At day 90 after start of dialysis
Mortality
Time Frame: At day 28 after start of dialysis
At day 28 after start of dialysis
Mortality
Time Frame: At day 60 after start of dialysis
At day 60 after start of dialysis
Mortality
Time Frame: At day 90 after start of dialysis
At day 90 after start of dialysis
Major adverse kidney events (MAKE)
Time Frame: At day 28 after start of dialysis
Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction
At day 28 after start of dialysis
Major adverse kidney events (MAKE)
Time Frame: At day 60 after start of dialysis
Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction
At day 60 after start of dialysis
Major adverse kidney events (MAKE)
Time Frame: At day 90 after start of dialysis
Composite endpoint consisting of death, renal replacement therapy, and persistent renal dysfunction
At day 90 after start of dialysis

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Transmigration of neutrophils
Time Frame: At initiation of dialysis
At initiation of dialysis
Transmigration of neutrophils
Time Frame: 24 hours after initiation of dialysis
24 hours after initiation of dialysis
Transmigration of neutrophils
Time Frame: 48 hours after initiation of dialysis
48 hours after initiation of dialysis
Transmigration of neutrophils
Time Frame: 72 hours after initiation of dialysis
72 hours after initiation of dialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Muenster

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baxter Healthcare Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexander Zarbock, MD, University Hospital Munster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10-AnIt-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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