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NCT Number: NCT06021288

Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT ( KETZEREI )

Acute kidney injury (AKI) is a well-recognized complication in critically ill patients, which often leads to the necessity of mechanical kidney support (CRRT).

In current therapeutic regimes, CRRT is used to strictly prevent azotaemia. Thus recent clinical observations, as well as data from animal testing suggest a link between controlled azotaemia and faster renal recovery in AKI patients.

The aim of the study is to improve renal recovery.

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Key information

Conditions

Critical Illness Acute Kidney Injury Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Münster, Münster, Germany

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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 AKI + in need of CRRT
  • Written informed consent

Exclusion criteria

  • Chronic dialysis dependency
  • Chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m²
  • severe liver cirrhosis (Child-pugh C)
  • severe acidosis (pH < 7,20 at study enrolment)
  • severe hyperkalaemia (> 6mmol/l)
  • Pregnancy or breastfeeding
  • persons held in an institution by legal or official order
  • Dependency on the investigator or center

Treatment and study plan

Effluent dose of CRRT

Other

The effluent dose of the CRRT will be performed according to study group for 7 days or up to the end of CRRT, whatever occurs first.

Primary outcomes

  1. Number of days alive and free from CRRT

    Time frame: Between Randomization and day 28

Secondary outcomes

  1. Number of Adverse Events (rooted in uraemia, i.e. throwing up, seizures, uremic coma etc.)

    Time frame: Between randomization and day 28

  2. Number of days with renal replacement therapy

    Time frame: Between randomization and day 28

  3. Length of Intensive Care Unit (ICU) stay

    Time frame: Between randomization and day 28

  4. Length of Hospital stay

    Time frame: Between randomization and day 28

  5. Mortality

    Time frame: Day 30 after randomization

  6. Number of new infections since randomization

    Time frame: From randomization until day 30

  7. Total amount of dialysis fluid utilized adjusted for weight

    Time frame: From randomization until day 30

  8. Number of patients alive and dialysis-free at day 30

    Time frame: Day 30 after randomization

  9. Presence of Major adverse kidney events (MAKE)

    Time frame: Day 30 after randomization

    Composite endpoint consisting of death, renal replacement therapy, and persistent severe AKI lasting for 72 hours or more

  10. Expense of treatment (including hospital stay/all measures taken)

    Time frame: From randomization until day 30 after randomization

Study contacts

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

Alexander Zarbock, MD

CONTACT

[email protected]

+492518347255

Melanie Meersch-Dini, MD

CONTACT

[email protected]

+492518347255

Sponsors and collaborators

Lead sponsor

Universität Münster

Other

Registry information

Official study title

A Randomized Controlled Study Investigating Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT - The "Ketzerei" Trial

Acronym: KETZEREI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2023
Registry last updated
Nov 27, 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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