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

Sepsis Clinical Trial

Official title:

Dialysis With CARPEDIEM®: French Multicentric Experience in 25 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05495607
• Other study ID #: 22-NEPHRO-01
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Cardiac Disease
• Fetofetal Transfusion
• Heart Diseases
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Kidney Diseases
• Metabolic Disease
• Metabolic Diseases
• Pulmonary Disease
• Sepsis
• Twin to Twin Transfusion Syndrome

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