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

Primary Purpose

Critical Illness, Acute Kidney Injury

Status

Not yet recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Effluent dose of CRRT

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring Continuous renal replacement therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Münster

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

CRRT will be established with a draining dose (effluent dose) of 10-15ml/kg/h in pursuit of establishing a controlled azotaemia.

Standard of Care: CRRT will be established with a draining dose (effluent dose) of 25-30ml/kg/h

Outcomes

Primary Outcome Measures

Number of days alive and free from CRRT

Secondary Outcome Measures

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

Number of days with renal replacement therapy

Length of Intensive Care Unit (ICU) stay

Length of Hospital stay

Mortality

Number of new infections since randomization

Total amount of dialysis fluid utilized adjusted for weight

Number of patients alive and dialysis-free at day 30

Presence of Major adverse kidney events (MAKE)

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

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

Full Information

NCT ID

NCT06021288

First Posted

August 15, 2023

Last Updated

August 31, 2023

Sponsor

Westfälische Wilhelms-Universität Münster

1. Study Identification

Unique Protocol Identification Number

NCT06021288

Brief Title

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

Acronym

KETZEREI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2023 (Anticipated)

Primary Completion Date

April 30, 2025 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Westfälische Wilhelms-Universität Münster

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness, Acute Kidney Injury

Keywords

Continuous renal replacement therapy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

CRRT will be established with a draining dose (effluent dose) of 10-15ml/kg/h in pursuit of establishing a controlled azotaemia.

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Standard of Care: CRRT will be established with a draining dose (effluent dose) of 25-30ml/kg/h

Intervention Type

Other

Intervention Name(s)

Effluent dose of CRRT

Intervention Description

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 Outcome Measure Information:

Title

Number of days alive and free from CRRT

Time Frame

Between Randomization and day 28

Secondary Outcome Measure Information:

Title

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

Time Frame

Between randomization and day 28

Title

Number of days with renal replacement therapy

Time Frame

Between randomization and day 28

Title

Length of Intensive Care Unit (ICU) stay

Time Frame

Between randomization and day 28

Title

Length of Hospital stay

Time Frame

Between randomization and day 28

Title

Mortality

Time Frame

Day 30 after randomization

Title

Number of new infections since randomization

Time Frame

From randomization until day 30

Title

Total amount of dialysis fluid utilized adjusted for weight

Time Frame

From randomization until day 30

Title

Number of patients alive and dialysis-free at day 30

Time Frame

Day 30 after randomization

Title

Presence of Major adverse kidney events (MAKE)

Description

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

Time Frame

Day 30 after randomization

Title

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

Time Frame

From randomization until day 30 after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexander Zarbock, MD

Phone

+492518347255

aki@anit.uni-muenster.de

First Name & Middle Initial & Last Name or Official Title & Degree

Melanie Meersch-Dini, MD

Phone

+492518347255

aki@uni-muenster.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Zarbock, MD

Organizational Affiliation

WWU Münster

Official's Role

Study Chair

Facility Information:

Facility Name

University Hospital Münster

City

Münster

ZIP/Postal Code

48149

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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