Retrospective Data Analysis of CKRT (Continuous Kidney Re... | NCT06236984

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2024Actual

Primary Completion Date

Feb 21, 2025Actual

Completion Date

Feb 21, 2025Actual

First Submitted Date

Jan 5, 2024

First Submission Date that Met QC Criteria

Jan 24, 2024

First Posted Date

Feb 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2025

Last Update Posted Date

Jun 10, 2025Actual

Name	Class
Metronomia Clinical Research GMBH	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The multiFiltratePRO is a device for extracorporeal blood purification treatments.

In this retrospective analysis, the treatments of patients who received at least one treatment with the investigational device as mentioned between January 2015 and January 2024 will be documented in a chronological order. No further control treatments will be investigated in this one-arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the multiFiltratePRO system.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AKI patients		Patients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment	Other: multiFiltratePRO with all CKRT treatment modes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
multiFiltratePRO with all CKRT treatment modes	Other	Retrospective Data Analysis of CKRT treatments in adult mode with multiFiltratePRO	AKI patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of treatments with multiFiltratePRO	Performance data of defined multiFiltratePRO CKRT treatments in adult mode with regard to fluid balance (effluent dose) are analysed	documentation of max.7 treatment days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment for at least once with: Heparin-Continuous veno-venous hemofiltration Hep-CVVH (Pre CVVH, Post CVVH and Pre-Post CVVH), Heparin-Continuous veno-venous hemodialysis Hep-CVVHD, Heparin-Continuous veno-venous hemodiafiltration Hep-CVVHDF (Pre-CVVHDF and Post-CVVHDF), Citrate-Calcium(Ci-Ca)-CVVHD, Citrate-Calcium(Ci-Ca) CVVHDF, between January 2015 and January 2024, with the investigational device, have to be included in the study in chronological order.
No age restriction for heparin modes
Age ≥ 18 years for Ci-Ca modes at treatment start
Patient´s body weight ≥ 40kg irrespective of age
Acute Kidney Injury (AKI) OR chronic dialysis patients with clinical indication for CKRT

Exclusion Criteria:

Participation in an interventional clinical study during the retrospectively collected CKRT treatment data
Previous participation in the same study
No study-specific exclusion criteria based on contraindications due to the retrospective character of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients with an indication for the extracorporeal blood treatment suffering from AKI who received CKRT adult mode treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rainer Borgstedt, Dr. med.	Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Evangelisches Klinikum Bethel gGmbH Universitätsklinikum OWL der Universität Bielefeld		Bielefeld	North Rhine-Westphalia	33617	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D058186	Acute Kidney Injury
D051437	Renal Insufficiency

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases