Clinical trial NCT05315817: Safety and Performance Evaluation of multiPlus Dialysate During CRRT
Official title: Safety and Performance Evaluation of multiPlus Dialysate During CRRT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Renal replacement therapy
Acute kidney injury
Haemodialysis
Haemodiafiltration
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: Winicker Norimed GmbH
First posted: 2022-04-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-comparative, multi-centre, open-label, interventional, post market clinical follow-up (PMCF) study
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Serum creatinine removal
timeFrame: 360 min after start
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Leipzig Heart Institute GmbH
state: Sachsen
Study officials:
affiliation: Helios Health Institute GmbH
name: Michael A. Borger, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: