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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05495607
Other study ID # 22-NEPHRO-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date January 1, 2022

Study information

Verified date August 2022
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 0 Years to 3 Years
Eligibility 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

Study Design


Intervention

Device:
CARPEDIEN
Continuous renal replacement therapy

Locations

Country Name City State
France CHU de Nice Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival 3 years
Primary Serum creatinine 3 years
Primary Serum potassium 3 years
Primary Blood urea nitrogen 3 years
Primary Ammonia levels 3 years
Secondary Ultrafiltration flow the substitution range with the effluent volume in ml/kg/h ( compared to the KDIGO recommend of 25-35 ml/kg/h) 3 years
Secondary Blood flow The range of blood flow in ml/kg/min ( compared to the recommend blood flow of 3-10 ml/kg/min). 3 years
Secondary Anticoagulation The dose of continuous heparin anticoagulation in UI/Kg/h to prevent circuit clotting. 3 years
Secondary Number of sessions 3 years
Secondary Time of treatments 3 years
Secondary CKRT modality 3 years
Secondary Vascular access The localization of a vascular access ( intern jugular, subclavian, umbilical or femoral). 3 years
Secondary Priming circuit The priming circuit ( normal salin, albumin, Isofundin or packed red blood cells). 3 years
Secondary Size of the circuit 3 years
Secondary Death 3 years
Secondary Clotting circuit and other dysfunction circuit Dysfunction circuit included cathether dysfunction, pressure dysfucntion and failure restitution
Complications of an extra corporel therapy including hypotension, thrombocytopenia and clotting circuit.
3 years
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