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

Completed

• Conditions: Sepsis; Pulmonary Disease; Kidney Diseases; Twin to Twin Transfusion Syndrome; Metabolic Disease; Hypoxic-Ischemic Encephalopathy; Cardiac Disease
• Interventions: Device: CARPEDIEN

• Registration Number: NCT05495607
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-10
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

-Renal replacement therapy with another device than Carpediem machine

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	CARPEDIEN	We have included 25 neonates and small infants having received CARPEDIEM® machine in France in a multicentric experience

Primary Outcome Measures

Name	Time	Method
Blood urea nitrogen	3 years
Survival	3 years
Serum creatinine	3 years
Serum potassium	3 years
Ammonia levels	3 years

Secondary Outcome Measures

Name	Time	Method
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)
Time of treatments	3 years
Number of sessions	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).
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.
Size of the circuit	3 years
Death	3 years
CKRT modality	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.

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France