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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Completed

CT.gov ID

NCT05495607

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxic-Ischemic Encephalopathy Sepsis Kidney Diseases Metabolic Disease Twin to Twin Transfusion Syndrome Cardiac Disease Pulmonary Disease	Device: CARPEDIEN

Study Design

Study Type:

Observational

Actual Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Dialysis With CARPEDIEM®: French Multicentric Experience in 25 Patients

Actual Study Start Date :

Dec 1, 2018

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients We have included 25 neonates and small infants having received CARPEDIEM® machine in France in a multicentric experience	Device: CARPEDIEN Continuous renal replacement therapy

Arm

Intervention/Treatment

Patients

We have included 25 neonates and small infants having received CARPEDIEM® machine in France in a multicentric experience

Device: CARPEDIEN

Continuous renal replacement therapy

Outcome Measures

Primary Outcome Measures

Survival [3 years]
Serum creatinine [3 years]
Serum potassium [3 years]
Blood urea nitrogen [3 years]
Ammonia levels [3 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 3 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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