Safety and Performance Evaluation of multiPlus Dialysate During CRRT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2023-01-24

Brief Summary

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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).

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Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, non-comparative, multi-centre, open-label, interventional, post market clinical follow-up (PMCF) study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

multiPlus dialysate

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No