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Clinical Trials/NCT05495607
NCT05495607CompletedNot Applicable

Dialysis With CARPEDIEM®: French Multicentric Experience in 25 Patients

Centre Hospitalier Universitaire de Nice1 site in 1 country25 target enrollmentStarted: December 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
1
Primary Endpoint
Serum potassium

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
0 Years to 3 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Renal replacement therapy with another device than Carpediem machine

Outcomes

Primary Outcomes

Serum potassium

Time Frame: 3 years

Survival

Time Frame: 3 years

Serum creatinine

Time Frame: 3 years

Blood urea nitrogen

Time Frame: 3 years

Ammonia levels

Time Frame: 3 years

Secondary Outcomes

  • Ultrafiltration flow(3 years)
  • Time of treatments(3 years)
  • Number of sessions(3 years)
  • Vascular access(3 years)
  • Priming circuit(3 years)
  • Blood flow(3 years)
  • Anticoagulation(3 years)
  • Size of the circuit(3 years)
  • Death(3 years)
  • CKRT modality(3 years)
  • Clotting circuit and other dysfunction circuit(3 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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