Skip to main content
OpenTrials
Completed

NCT Number: NCT05495607

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypoxic-Ischemic Encephalopathy Anemia Anemia, Neonatal Brain Diseases Brain Ischemia Cardiac Disease Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fetofetal Transfusion Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Infant, Newborn, Diseases Infections Inflammation Kidney Diseases Lung Diseases Male Urogenital Diseases Metabolic Disease Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease Respiratory Tract Diseases Sepsis Signs and Symptoms Signs and Symptoms, Respiratory Systemic Inflammatory Response Syndrome Twin to Twin Transfusion Syndrome Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

0 year–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CARPEDIEN

Device

Continuous renal replacement therapy

Primary outcomes

  1. Survival

    Time frame: 3 years

  2. Serum creatinine

    Time frame: 3 years

  3. Serum potassium

    Time frame: 3 years

  4. Blood urea nitrogen

    Time frame: 3 years

  5. Ammonia levels

    Time frame: 3 years

Secondary outcomes

  1. Ultrafiltration flow

    Time frame: 3 years

    the substitution range with the effluent volume in ml/kg/h ( compared to the KDIGO recommend of 25-35 ml/kg/h)

  2. Blood flow

    Time frame: 3 years

    The range of blood flow in ml/kg/min ( compared to the recommend blood flow of 3-10 ml/kg/min).

  3. Anticoagulation

    Time frame: 3 years

    The dose of continuous heparin anticoagulation in UI/Kg/h to prevent circuit clotting.

  4. Number of sessions

    Time frame: 3 years

  5. Time of treatments

    Time frame: 3 years

  6. CKRT modality

    Time frame: 3 years

  7. Vascular access

    Time frame: 3 years

    The localization of a vascular access ( intern jugular, subclavian, umbilical or femoral).

  8. Priming circuit

    Time frame: 3 years

    The priming circuit ( normal salin, albumin, Isofundin or packed red blood cells).

  9. Size of the circuit

    Time frame: 3 years

  10. Death

    Time frame: 3 years

  11. Clotting circuit and other dysfunction circuit

    Time frame: 3 years

    • Dysfunction circuit included cathether dysfunction, pressure dysfucntion and failure restitution
    • Complications of an extra corporel therapy including hypotension, thrombocytopenia and clotting circuit.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Dialysis With CARPEDIEM®: French Multicentric Experience in 25 Patients

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2022
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.