Safety and Performance Evaluation of multiPlus Dialysate... | NCT05315817

Studies
Safety and Performance Evaluation of multiPlus Dialysate During CRRT

NCT05315817

Sponsor

Fresenius Medical Care Deutschland GmbH

Status

Terminated

Last Update Posted

Jan 9, 2024Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Acute Kidney Injury

Interventions

multiPlus dialysate

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Internal reasons

Expanded Access Info

Start Date

May 31, 2022Actual

Primary Completion Date

Oct 28, 2022Actual

Completion Date

Jan 24, 2023Actual

First Submitted Date

Mar 30, 2022

First Submission Date that Met QC Criteria

Mar 30, 2022

First Posted Date

Apr 7, 2022Actual

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

Jan 5, 2024

Last Update Posted Date

Jan 9, 2024Actual

Name	Class
Winicker Norimed GmbH	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
multiPlus dialysate	Experimental	Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate.	Device: multiPlus dialysate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
multiPlus dialysate	Device	Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate.

Measure	Description	Time Frame
Serum creatinine removal	The primary variable of this clinical investigation is serum creatinine removal (arterial pre-filter sample taking) assessed 6 hours (360 min) after start of CVVHD(F).	360 min after start

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed and dated informed consent form by investigator and by
- a) the study patient: if patient is able to consent
- b) the legal representative: if patient is unable to consent:
- c) an independent consultant: in case of emergency
if c) either legal representative or study patient, whichever can be done sooner, should be informed by the investigator as soon as possible. If the informed consent has been obtained by the legal representative (b or emergency scenario) informed consent to continue the participation in the clinical investigation shall be obtained from the subject as soon as he or she is capable of giving informed consent (According to the MDR - Article 68 - Clinical investigations in emergency situations)
Minimum age of 18 years
Ability to understand the nature and requirements of the study (if patient is conscious)

Study specific:

Body weight greater than 40 kg
Acute Kidney Injury (AKI) with clinical indication for CVVHD/CVVHDF
Vascular access allowing blood flow of min 50mL/min
Estimated life expectancy greater than 3 days

Exclusion Criteria:

Any conditions which could interfere with the patient's ability to comply with the study
In case of female patients: pregnancy (negative pregnancy test for women below 55 years) or lactation period
Participation in an interventional clinical study during the preceding 30 days
Previous participation in the same study
SARS-CoV 2 positive

Study specific

Hyperphosphataemia (>4.5 mg/dL)
Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II)
Uncontrolled bleeding and coagulation disorders
Decision to limit therapeutic interventions
Advanced malignancy (not including myeloma)
Dementia (if definitely not an acute confusional state from uraemia or other acute illness)
Advanced cirrhosis with encephalopathy in the absence of possible liver transplantation

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

Not provided

Sampling Method

Not provided

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases