Hypoxic-Ischemic EncephalopathyNCT05495607
Continous Renal Replacement Therapy With the CARPEDIEM® in a French National Cohort of 25 Neonates and Small Infants
An observational study of Hypoxic-Ischemic Encephalopathy and Sepsis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 0 to 3 years
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Sepsis, Kidney Diseases
- What is being tested?
- CARPEDIEN
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: The population will be selected in a department of pediatric and neonatal unit intensive care and whom need a renal replacement therapy
Who may be able to join
- 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
Who cannot join
- -Renal replacement therapy with another device than Carpediem machine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dialysis With CARPEDIEM®: French Multicentric Experience in 25 Patients
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
- Being tested
- CARPEDIEN
- Medical subject headings
- Hypoxia-Ischemia, Brain, Sepsis, Kidney Diseases, Metabolic Diseases, Fetofetal Transfusion, Heart Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARPEDIENDevice
Continuous renal replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| Patients | We have included 25 neonates and small infants having received CARPEDIEM® machine in France in a multicentric experience Receives: Device: CARPEDIEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 3 years
Serum creatinine
Measured: 3 years
Serum potassium
Measured: 3 years
Blood urea nitrogen
Measured: 3 years
Ammonia levels
Measured: 3 years
Secondary outcomes (11)
Ultrafiltration flow
the substitution range with the effluent volume in ml/kg/h ( compared to the KDIGO recommend of 25-35 ml/kg/h)
Measured: 3 years
Blood flow
The range of blood flow in ml/kg/min ( compared to the recommend blood flow of 3-10 ml/kg/min).
Measured: 3 years
Anticoagulation
The dose of continuous heparin anticoagulation in UI/Kg/h to prevent circuit clotting.
Measured: 3 years
Number of sessions
Measured: 3 years
Time of treatments
Measured: 3 years
CKRT modality
Measured: 3 years
Vascular access
The localization of a vascular access ( intern jugular, subclavian, umbilical or femoral).
Measured: 3 years
Priming circuit
The priming circuit ( normal salin, albumin, Isofundin or packed red blood cells).
Measured: 3 years
Size of the circuit
Measured: 3 years
Death
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Dec 2018
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495607
- Sponsor's protocol ID
- 22-NEPHRO-01
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialysis With CARPEDIEM®: French Multicentric Experience in 25 Patients
- ClinicalTrials.gov ID
- NCT05495607
- Acronym / sponsor ID
- 22-NEPHRO-01
- Conditions
- Hypoxic-Ischemic Encephalopathy, Sepsis, Kidney Diseases, Metabolic Disease, Twin to Twin Transfusion Syndrome, Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: CARPEDIENWe have included 25 neonates and small infants having received CARPEDIEM® machine in France in a multicentric experience |
Who may qualify
- Ages
- 0 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The population will be selected in a department of pediatric and neonatal unit intensive care and whom need a renal replacement therapy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -Renal replacement therapy with another device than Carpediem machine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARPEDIENContinuous renal replacement therapy | Device | Patients |
Primary outcome
Survival
Time frame: 3 years
Serum creatinine
Time frame: 3 years
Serum potassium
Time frame: 3 years
Blood urea nitrogen
Time frame: 3 years
Ammonia levels
Time frame: 3 years
11 secondary outcomes
Ultrafiltration flow
Time frame: 3 years
Blood flow
Time frame: 3 years
Anticoagulation
Time frame: 3 years
Number of sessions
Time frame: 3 years
Time of treatments
Time frame: 3 years
CKRT modality
Time frame: 3 years
Vascular access
Time frame: 3 years
Priming circuit
Time frame: 3 years
Size of the circuit
Time frame: 3 years
Death
Time frame: 3 years
Clotting circuit and other dysfunction circuit
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic-Ischemic Encephalopathy and Sepsis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.