Safety and Performance Evaluation of multiPlus Dialysate During CRRT

Fresenius Medical Care (FMC)

Status: Terminated

Conditions: Acute Kidney Injury

Treatments: Device: multiPlus dialysate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05315817

CRRT-CVVHD(F)/MP-01-D

Details and patient eligibility

About

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).

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

multiPlus dialysate

Experimental group

Description:

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

Treatment:

Device: multiPlus dialysate