NCT05315817

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2023

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

March 30, 2022

Last Update Submit

January 5, 2024

Conditions

Acute Kidney Injury

Keywords

Renal replacement therapyAcute kidney injuryHaemodialysisHaemodiafiltration

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

multiPlus dialysate

EXPERIMENTAL

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

Interventions

multiPlus dialysateDEVICE

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

multiPlus dialysate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leipzig Heart Institute GmbH

Leipzig, Saxony, 04289, Germany

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Michael A. Borger, Prof Dr

    Helios Health Institute GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, non-comparative, multi-centre, open-label, interventional, post market clinical follow-up (PMCF) study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 7, 2022

Study Start

May 31, 2022

Primary Completion

October 28, 2022

Study Completion

January 24, 2023

Last Updated

January 9, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)