Safety and Performance Evaluation of multiPlus Dialysate During CRRT

Acute Kidney Injury Clinical Trial

— multiPlus  

Official title:

Safety and Performance Evaluation of multiPlus Dialysate During CRRT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05315817
• Other study ID #: CRRT-CVVHD(F)/MP-01-D
• Status: Terminated
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: January 24, 2023

Study information

• Verified date: December 2023
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 24, 2023
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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.

Locations

Country	Name	City	State
Germany	Leipzig Heart Institute GmbH	Leipzig	Sachsen

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH	Winicker Norimed GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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