Kidney DiseasesNCT04193865
Hemofilter Life Span, ECLS And/or CRRT
An observational study of Kidney Diseases and Acute Injury of Kidney, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The goal of this project to better understand the immune-modulatory effects of continuous renal replacement therapy (CRRT) in neonatal and pediatric patients, particularly those receiving extracorporeal life support (ECLS). Read more about this study
- Who is it for?
- Ages 0 days to 17 years
- Conditions the study is for
- Kidney Diseases, Acute Injury of Kidney, Renal Failure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 25 Mar 2024
- 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 days to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Both male and female neonatal (aged 0-28 days of life) and pediatric (children aged 29 days-17 years) patients receiving ECLS will be eligible. The study team will also enroll neonatal and pediatric patients receiving CRRT alone (no ECLS).
Who may be able to join
- Neonatal or pediatric patients receiving ECLS (>2 kilograms and >34 weeks gestation)
- CRRT utilized during ECLS course
- For the secondary endpoints comparing CRRT-mediated cytokine filtration in patients receiving ECLS with concurrent CRRT to patients receiving CRRT alone (no ECLS), the investigators will also enroll neonatal and pediatric patients receiving CRRT alone (no ECLS). Patients will be eligible for entry into this study if they meet all of the following criteria:
- Neonatal or pediatric patients receiving CRRT
Who cannot join
- -Those patients with inability or unwillingness of legal guardian/representative to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Univeristy of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Hemofilter Life Span and Filtration of Inflammatory Markers in Patients Receiving Extracorporeal Life Support And/or Continuous Renal Replacement Therapy
The goal of this project to better understand the immune-modulatory effects of continuous renal replacement therapy (CRRT) in neonatal and pediatric patients, particularly those receiving extracorporeal life support (ECLS). Little is known about the effects of CRRT in this particular population and improved knowledge will be useful clinically and may lead to novel therapeutic approaches and improved outcomes for these critically ill patients.
Read the detailed description
Via collection of serum and ultrafiltrate samples, the invesitgators will examine how hemofilter lifespan alters the filtration of pro- and anti-inflammatory cytokines.
- Conditions
- Kidney Diseases, Acute Injury of Kidney, Renal Failure, Renal Insufficiency, Neonatal Renal Disorder (Disorder)
- Keywords
- Extracorporeal life support, Extracorporeal membrane oxygenation, Acute Kidney Injury, Renal replacement therapy, Renal Support therapy, Kidney support therapy
- Medical subject headings
- Kidney Diseases, Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Life Support with Renal Replacement Therapy | This cohort will include all subjects receiving extracorporeal life support with concurrent continuous renal replacement therapy. Two blood samples and one ultrafiltration sample will be obtained for the study protocol twice per day (every 12 hours) for the duration of each participants's CRRT course. | |
| Renal Replacement Therapy | This cohort will include all subjects receiving continuous renal replacement therapy (no extracorporeal life support). Two blood samples and one ultrafiltration sample will be obtained for the study protocol twice per day (every 12 hours) for the duration of each patient's CRRT course. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine concentrations over time (every 12 hours for the entire course of CRRT)
Quantify cytokine concentrations, specifically interferon (IFN)- γ, interleukin (IL)-1β, IL-6, IL-8, IL-10, IL-12p70, tumor necrosis factor (TNF)-α (all to result in concentrations in pg/ml), in pre-CRRT filter serum, post-CRRT filter serum, and ultrafiltrate (UF) using electrochemiluminescene assay and cytometric bead array and determine how age of the CRRT filter influences filtration of these cytokines.
Measured: Cytokine concentrations over time every 12 hours for the entire course of CRRT through study completion, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start9 Jan 2020
- Primary completion1 Mar 2023
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Heidi Murphy, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193865
- Sponsor's protocol ID
- 00094177
- Status last verified
- Oct 2024
- First submitted
- 18 Nov 2019
- Last updated
- 28 Oct 2024
- 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 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemofilter Life Span and Filtration of Inflammatory Markers in Patients Receiving Extracorporeal Life Support And/or Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT04193865
- Acronym / sponsor ID
- 00094177
- Conditions
- Kidney Diseases, Acute Injury of Kidney, Renal Failure, Renal Insufficiency, Neonatal Renal Disorder (Disorder)
- Keywords
- Extracorporeal life support, Extracorporeal membrane oxygenation, Acute Kidney Injury, Renal replacement therapy, Renal Support therapy, Kidney support therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 10 Dec 2019 (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.
The goal of this project to better understand the immune-modulatory effects of continuous renal replacement therapy (CRRT) in neonatal and pediatric patients, particularly those receiving extracorporeal life support (ECLS). Little is known about the effects of CRRT in this particular population and improved knowledge will be useful clinically and may lead to novel therapeutic approaches and improved outcomes for these critically ill patients.
Detailed description
Via collection of serum and ultrafiltrate samples, the invesitgators will examine how hemofilter lifespan alters the filtration of pro- and anti-inflammatory cytokines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Life Support with Renal Replacement Therapy | – | –This cohort will include all subjects receiving extracorporeal life support with concurrent continuous renal replacement therapy. Two blood samples and one ultrafiltration sample will be obtained for the study protocol twice per day (every 12 hours) for the duration of each participants's CRRT course. |
| Renal Replacement Therapy | – | –This cohort will include all subjects receiving continuous renal replacement therapy (no extracorporeal life support). Two blood samples and one ultrafiltration sample will be obtained for the study protocol twice per day (every 12 hours) for the duration of each patient's CRRT course. |
Who may qualify
- Ages
- 0 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Both male and female neonatal (aged 0-28 days of life) and pediatric (children aged 29 days-17 years) patients receiving ECLS will be eligible. The study team will also enroll neonatal and pediatric patients receiving CRRT alone (no ECLS).
Key inclusion criteria (4 listed)
- Neonatal or pediatric patients receiving ECLS (>2 kilograms and >34 weeks gestation)
- CRRT utilized during ECLS course
- For the secondary endpoints comparing CRRT-mediated cytokine filtration in patients receiving ECLS with concurrent CRRT to patients receiving CRRT alone (no ECLS), the investigators will also enroll neonatal and pediatric patients receiving CRRT alone (no ECLS). Patients will be eligible for entry into this study if they meet all of the following criteria:
- Neonatal or pediatric patients receiving CRRT
Key exclusion criteria (1 listed)
- -Those patients with inability or unwillingness of legal guardian/representative to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cytokine concentrations over time (every 12 hours for the entire course of CRRT)
Time frame: Cytokine concentrations over time every 12 hours for the entire course of CRRT through study completion, up to 12 months
Quantify cytokine concentrations, specifically interferon (IFN)- γ, interleukin (IL)-1β, IL-6, IL-8, IL-10, IL-12p70, tumor necrosis factor (TNF)-α (all to result in concentrations in pg/ml), in pre-CRRT filter serum, post-CRRT filter serum, and ultrafiltrate (UF) using electrochemiluminescene assay and cytometric bead array and determine how age of the CRRT filter influences filtration of these cytokines.
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 28 Oct 2024.
- 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.
Heidi Murphy, MD principal investigator
Medical University of South Carolina
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 Kidney Diseases and Acute Injury of Kidney, run by Medical University of South Carolina at 1 site in United States.
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 4 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 28 Oct 2024. 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 United States. 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?
Cytokine concentrations over time (every 12 hours for the entire course of CRRT) (time frame: Cytokine concentrations over time every 12 hours for the entire course of CRRT through study completion, up to 12 months). 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 28 Oct 2024.