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Safety and Performance Evaluation of multiPlus Dialysate During CRRT (multiPlus)

Primary Purpose

Acute Kidney Injury

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
multiPlus dialysate
Sponsored by
Fresenius Medical Care Deutschland GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Renal replacement therapy, Acute kidney injury, Haemodialysis, Haemodiafiltration

Eligibility Criteria

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

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

Sites / Locations

  • Leipzig Heart Institute GmbHRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

multiPlus dialysate

Arm Description

Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 30, 2022
Last Updated
August 1, 2022
Sponsor
Fresenius Medical Care Deutschland GmbH
Collaborators
Winicker Norimed GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05315817
Brief Title
Safety and Performance Evaluation of multiPlus Dialysate During CRRT
Acronym
multiPlus
Official Title
Safety and Performance Evaluation of multiPlus Dialysate During CRRT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Medical Care Deutschland GmbH
Collaborators
Winicker Norimed GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Assessment of the performance of multiPlus dialysate based on the serum creatinine removal 6 hours (360 min) after start of continuous veno-venous haemodialysis/ haemodiafiltration [CVVHD(F)]. multiPlus is a phosphate-containing dialysis solution for the use in continuous renal replacement therapy (CRRT) during acute kidney injury (AKI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Renal replacement therapy, Acute kidney injury, Haemodialysis, Haemodiafiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, non-comparative, multi-centre, open-label, interventional, post market clinical follow-up (PMCF) study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
multiPlus dialysate
Arm Type
Experimental
Arm Description
Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate.
Intervention Type
Device
Intervention Name(s)
multiPlus dialysate
Intervention Description
Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate.
Primary Outcome Measure Information:
Title
Serum creatinine removal
Description
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).
Time Frame
360 min after start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuela Stauss-Grabo, Dr
Phone
+4961726085248
Email
Manuela.Stauss-Grabo@fmc-ag.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Schwarzkopf
Phone
+49 6172 608 945 62
Email
Christoph.schwarzkopf@fmc-ag.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Borger, Prof Dr
Organizational Affiliation
Helios Health Institute GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leipzig Heart Institute GmbH
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael A. Borger, Prof Dr
Phone
+49 341 865 1421
Email
michael.borger@helios-gesundheit.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Performance Evaluation of multiPlus Dialysate During CRRT

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