Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New kidney machine for tiny tots under scrutiny

NCT ID NCT04608149

Knowledge-focused Sponsor: Mozarc Medical US LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This study follows about 36 children weighing 2.5-10 kg who have acute kidney injury or fluid overload and are treated with the Carpediem continuous renal replacement therapy system. Researchers will track survival, kidney recovery, and hospital stay lengths to see how well the device works in real-world intensive care settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Carpediem™ system (continuous renal replacement therapy device)
What this could lead to
If successful, this study could confirm that the Carpediem system is safe and effective for treating kidney injury and fluid overload in small children.
What could go wrong
This is an observational study with no control group, so it cannot prove the device works better than other treatments. Results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

36 people

The number who actually took part.

Started

Jan 2021

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who have acute kidney injury or fluid overload requiring hemodialysis or hemofiltration who weigh between 2.5 and 10 kilograms (5.5 to 22 pounds).

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Parent or LAR has signed information consent * Subject weighs between 2.5-10 kg (or 5.5-22 lbs) * Subject is receiving medical care in an intensive care unit * Parental or LAR consent to receive full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours * Subject has a clinical diagnosis of acute kidney injury per Kidney Disease Improving Global Outcomes (KDIGO) criteria or fluid overload requiring CRRT Exclusion Criteria: * Subject is not expected to survive 72 hours due to an irreversible medical condition, in the opinion of the investigator * Subject has irreversible brain damage, in the opinion of the investigator * Subject is intolerant to anticoagulation, as documented in the medical record * Subject has a Do Not Attempt Resuscitate (DNAR), Allow Natural Death (AND), withdrawal of care or similar order, or anticipated change in status, in the opinion of the investigator, within the next 7 days * Subject has pre-existing end-stage renal disease or pre-existing, advanced chronic kidney disease, defined as an estimated Glomerular Filtration Rate (eGRF) \< 30 ml/min/1.73m2 * Subject is currently or has chronically been treated with a circulatory support device (i.e., left ventricular assist device (LVAD)) other than ECMO * Subject has had prior CRRT treatments using the Carpediem™ system * Subject is enrolled in clinical trials or being treated with other investigational therapeutic devices or products for acute kidney injury or fluid overload * Subject has any other medical condition that may confound the study objectives, in the opinion of the investigator

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute kidney injury are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute kidney injury Edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury Fluid overload

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Golisano Children's Hospital

    Rochester, New York, 14642, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Seattle Children's

    Seattle, Washington, 98103, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • University of Iowa Healthcare

    Iowa City, Iowa, 52252, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.