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Continous Renal Replacement Therapy With the CARPEDIEM® in a French National Cohort of 25 Neonates and Small Infants

Dialysis With CARPEDIEM®: French Multicentric Experience in 25 Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05495607
Enrollment
25
Registered
2022-08-10
Start date
2018-12-01
Completion date
2022-01-01
Last updated
2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease, Hypoxic-Ischemic Encephalopathy, Kidney Diseases, Metabolic Disease, Pulmonary Disease, Sepsis, Twin to Twin Transfusion Syndrome

Brief summary

Historically, CKRT and hemodialysis were performed in small infants and newborns with devices developed for adults with high rates of complications and mortality. We aim to retrospectively report the first multicenter French experience of CARPEDIEM® use and evaluate the efficacy, feasibility, outcomes, and technical considerations of this new device in a population of neonates and small infant. Compared to adult's device continuous renal replacement therapy with an adapted machine allowed successful blood purification without severe complications even in low birth weight neonates.

Interventions

DEVICECARPEDIEN

Continuous renal replacement therapy

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 3 Years
Healthy volunteers
No

Inclusion criteria

* Children and neonates including premature and low birth weight neonates * Have a diagnosis of acute kidney injury, end stage renal disease, metabolic disease, electrolyte abnormality * Require renal replacement therapy

Exclusion criteria

-Renal replacement therapy with another device than Carpediem machine

Design outcomes

Primary

MeasureTime frame
Survival3 years
Serum creatinine3 years
Serum potassium3 years
Blood urea nitrogen3 years
Ammonia levels3 years

Secondary

MeasureTime frameDescription
Blood flow3 yearsThe range of blood flow in ml/kg/min ( compared to the recommend blood flow of 3-10 ml/kg/min).
Anticoagulation3 yearsThe dose of continuous heparin anticoagulation in UI/Kg/h to prevent circuit clotting.
Number of sessions3 years
Vascular access3 yearsThe localization of a vascular access ( intern jugular, subclavian, umbilical or femoral).
CKRT modality3 years
Clotting circuit and other dysfunction circuit3 years* Dysfunction circuit included cathether dysfunction, pressure dysfucntion and failure restitution * Complications of an extra corporel therapy including hypotension, thrombocytopenia and clotting circuit.
Time of treatments3 years
Priming circuit3 yearsThe priming circuit ( normal salin, albumin, Isofundin or packed red blood cells).
Size of the circuit3 years
Death3 years
Ultrafiltration flow3 yearsthe substitution range with the effluent volume in ml/kg/h ( compared to the KDIGO recommend of 25-35 ml/kg/h)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026