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NCT Number: NCT05450185

Filter Lifespan in Continuous Renal Replacement Therapy

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.

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Key information

Conditions

Critically Ill Continuous Renal Replacement Therapy Critical Illness Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Univ.-Klinik Innsbruck, Innsbruck, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Critically ill patients with continuous renal replacement therapy

Procedure

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.

Primary outcomes

  1. Number of new infections since start of dialysis

    Time frame: From start of dialysis until day 28

Secondary outcomes

  1. Number of new blood stream infections

    Time frame: From start of dialysis until day 28

  2. Number of new pneumonia

    Time frame: From start of dialysis until day 28

  3. Number of new urinary tract infection

    Time frame: From start of dialysis until day 28

  4. Number of new catheter blood stream infection

    Time frame: From start of dialysis until day 28

  5. Number of new other infections

    Time frame: From start of dialysis until day 28

  6. Filter live span

    Time frame: From start of dialysis until day 28 or end of CRRT, whatever occurs first

  7. 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

  8. Down-time of CRRT in hours

    Time frame: From start of dialysis until day 28 or end of CRRT, whatever occurs first

  9. Days on renal replacement therapy

    Time frame: From start of dialysis until day 28

  10. Duration of mechanical ventilation in hours

    Time frame: From start of dialysis until day 28

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. Number of patients with need for kidney replacement therapy

    Time frame: At day 28 after start of dialysis

  16. Number of patients with need for kidney replacement therapy

    Time frame: At day 60 after start of dialysis

  17. Number of patients with need for kidney replacement therapy

    Time frame: At day 90 after start of dialysis

  18. Mortality

    Time frame: At day 28 after start of dialysis

  19. Mortality

    Time frame: At day 60 after start of dialysis

  20. Mortality

    Time frame: At day 90 after start of dialysis

  21. 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

  22. 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

  23. 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

Other outcomes

  1. Transmigration of neutrophils

    Time frame: At initiation of dialysis

  2. Transmigration of neutrophils

    Time frame: 24 hours after initiation of dialysis

  3. Transmigration of neutrophils

    Time frame: 48 hours after initiation of dialysis

  4. Transmigration of neutrophils

    Time frame: 72 hours after initiation of dialysis

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Zarbock, MD

CONTACT

[email protected]

+49-251-8347252

Melanie Meersch-Dini, MD

CONTACT

+49-251-47255

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study 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

Acronym: CRRTInfO

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2022
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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