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

NCT05495607 | Completed

• 1 other identifier: 22-NEPHRO-01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic-Ischemic Encephalopathy; Sepsis; Kidney Diseases; Metabolic Disease; Twin to Twin Transfusion Syndrome; Cardiac Disease; Pulmonary Disease

Outcome Measures

Primary Outcomes (5)

• Survival

  3 years

• Serum creatinine

  3 years

• Serum potassium

  3 years

• Blood urea nitrogen

  3 years

• Ammonia levels

  3 years

Secondary Outcomes (11)

• Ultrafiltration flow

  3 years

• Blood flow

  3 years

• Anticoagulation

  3 years

• Number of sessions

  3 years

• Time of treatments

  3 years

Study Arms (1)

Patients

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

Device: CARPEDIEN

Interventions

CARPEDIEN DEVICE

Continuous renal replacement therapy

Patients

Eligibility Criteria

• Age: 0 Years - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The population will be selected in a department of pediatric and neonatal unit intensive care and whom need a renal replacement therapy

You may qualify if:

• 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

You may not qualify if:

• Renal replacement therapy with another device than Carpediem machine

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, France

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Sepsis; Kidney Diseases; Metabolic Diseases; Fetofetal Transfusion; Heart Diseases; Lung Diseases

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nutritional and Metabolic Diseases; Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 10, 2022
• Study Start: December 1, 2018
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)