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

Study Overview
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Brief Summary
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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.

Official Title
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Dialysis With CARPEDIEM®: French Multicentric Experience in 25 Patients

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

Intervention / Treatment
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* Device: CARPEDIEN


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>We have included 25 neonates and small infants having received CARPEDIEM® machine in France in a multicentric experience | Device: CARPEDIEN<br>* Continuous renal replacement therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 3 years | 
| Serum creatinine |  | 3 years | 
| Serum potassium |  | 3 years | 
| Blood urea nitrogen |  | 3 years | 
| Ammonia levels |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Anticoagulation | The dose of continuous heparin anticoagulation in UI/Kg/h to prevent circuit clotting. | 3 years | 
| Number of sessions |  | 3 years | 
| Time of treatments |  | 3 years | 
| CKRT modality |  | 3 years | 
| Vascular access | The localization of a vascular access ( intern jugular, subclavian, umbilical or femoral). | 3 years | 
| Priming circuit | The priming circuit ( normal salin, albumin, Isofundin or packed red blood cells). | 3 years | 
| Size of the circuit |  | 3 years | 
| Death |  | 3 years | 
| 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 |