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

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).

Study Overview

• Status: Terminated
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Device: multiPlus dialysate

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Sachsen
    • Leipzig, Sachsen, Germany, 04289
      • Leipzig Heart Institute GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multiPlus dialysate; 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; Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fresenius Medical Care Deutschland GmbH
• Collaborators: Winicker Norimed GmbH
• Investigators: Principal Investigator: Michael A. Borger, Prof Dr, Helios Health Institute GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): October 28, 2022
• Study Completion (Actual): January 24, 2023

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Renal replacement therapy; Acute kidney injury; Haemodialysis; Haemodiafiltration
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: CRRT-CVVHD(F)/MP-01-D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No