Acute Renal FailureNCT01941823
Carnitine, Aclycarnitine, Myocardial Function, and CRRT
An observational study of Acute Renal Failure, run by Asha Moudgil at 1 site in United States.
Trial summary
Carnitine is essential for the transport of fatty acids into the mitochondria and energy production in different muscles, including the myocardium. It is also needed to protect myocyte cell membranes from oxidative damage by removing excess acyl carnitine groups. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Acute Renal Failure
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Oct 2019
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and young adults, age 1-21 years Critically ill, receiving care in intensive care unit
Patients
CRRT Study Group (n=10) Inclusion Criteria
- age 1-21 years
- Receiving CRRT in the PICU or CICU
- NPO or TPN-dependent Exclusion Criteria
- Children on chronic dialysis 4. Children on carnitine supplementation for a metabolic disorder 5. Children on CRRT for less than 1 week
Prospective Control Group (n=10) Inclusion Criteria 1. age 1-21years 2. Receiving care in the PICU or CICU, but not requiring CRRT 3. NPO or TPN-dependent Exclusion Criteria
- Children on chronic dialysis
- Children on carnitine supplementation for a metabolic disorder
Retrospective CRRT Control Group (n=10) Inclusion Criteria
- 1-21years of age
- Received CRRT between 2011-2015
- Had total and free carnitine level checked while on CRRT (2 values>1 week apart)
- Had echocardiogram (2 studies >1 week apart) Exclusion Criteria
- Receiving supplemental carnitine at time of carnitine level and/or echocardiogram 2. Congenital or acute heart disease 3. On ECMO
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Cetner
Washington D.C., District of Columbia, 20010
About this study
Official title: Pilot Study: Effect of Carnitine Supplementation on Acylcarnitine Profile and Myocardial Function in Children and Young Adults Receiving Continuous Renal Replacement Therapy
Carnitine is essential for the transport of fatty acids into the mitochondria and energy production in different muscles, including the myocardium. It is also needed to protect myocyte cell membranes from oxidative damage by removing excess acyl carnitine groups. Patients receiving chronic intermittent hemodialysis (HD) are known to be at increased risk for carnitine deficiency as a result of its removal during the dialysis procedure, lack of endogenous synthesis by the kidney, and inadequate dietary intake. The carnitine status of children undergoing continuous renal replacement therapy (CRRT) has not been studied. Children undergoing CRRT in the intensive care unit (ICU) setting may be at increased risk for carnitine deficiency due to its continuous removal, lack of carnitine production by the kidney, and absence of carnitine intake (as majority of these children can not eat and there is no carnitine added to total parenteral nutrition (TPN). Carnitine deficiency may increase the risk of cardiac dysfunction in critically ill children. This is the first study to examine carnitine status in children undergoing CRRT. Standard echo as well as more sensitive speckle tracking echo will be used to evaluate the effect of carnitine deficiency on myocardial function.
Read the detailed description
Study Design:The research design consists of a prospective study group that would be compared to two control groups (a prospective control groups and a retrospective control group). The study group will consist of critically ill children receiving CRRT and IV carnitine supplementation (added in the TPN). The prospective control group will consist of critically ill children not receiving CRRT or carnitine Retrospective control group will consist of critically ill children who received CRRT but did not receive carnitine supplementation. . Subjects for the prospective study and control groups will be recruited from the pediatric intensive care unit (PICU) and the cardiac intensive care unit (CICU) at Children's National. Informed consent will be obtained from participants enrolled in the prospective study and control groups. Data for the retrospective control group will be obtained from the medical record.
- Conditions
- Acute Renal Failure
- Keywords
- acute renal failure, CRRT, continuous dialysis, carnitine, cardiac strain
- Medical subject headings
- Acute Kidney Injury
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 |
|---|---|---|
| Carnitine CRRT, prospective | CRRT patients given carnitine in TPN as part of clinical protocol. Will evaluate total and free, carnitine and acylcarnitine profile as well as cardiac function by standard and speckle tracking echo weekly during CRRT. | |
| CRRT Control, retrospective | Retrospective control group, CRRT patients who did not receive carnitine supplementation during CRRT and had carnitine levels measured and echo performed during CRRT. | |
| ICU Control (non-CRRT), prospective | Critically ill ICU patients not receiving any exogenous carnitine, and not receiving CRRT, will have total and free carnitine and acylcarnitine profile measured weekly during CRRT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function of children receiving carnitine compared with controls during CRRT
Echocardiography parameters of children in the study group will be compared to those of the retrospective CRRT control group.
Measured: 1-3 weeks
Secondary outcomes (1)
Carnitine deficiency in children receiving CRRT
Total and free carnitine levels and acylcarnitine profile of the 3 study cohorts will be compared with published normal levels in children.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startDec 2014
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asha Moudgil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asha Moudgil, Children's National Research Institute
- Investigators
- Asha Moudgil, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941823
- Sponsor's protocol ID
- 00003555
- Status last verified
- Jan 2020
- First submitted
- 10 Sep 2013
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sgambat K, Moudgil A. Carnitine deficiency in children receiving continuous renal replacement therapy. Hemodial Int. 2016 Jan;20(1):63-7. doi: 10.1111/hdi.12341. Epub 2015 Aug 11.
PubMed 26265013
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Effect of Carnitine Supplementation on Acylcarnitine Profile and Myocardial Function in Children and Young Adults Receiving Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT01941823
- Acronym / sponsor ID
- 00003555
- Conditions
- Acute Renal Failure
- Keywords
- acute renal failure, CRRT, continuous dialysis, carnitine, cardiac strain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Asha MoudgilUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 13 Sep 2013 (estimated)
- 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.
Carnitine is essential for the transport of fatty acids into the mitochondria and energy production in different muscles, including the myocardium. It is also needed to protect myocyte cell membranes from oxidative damage by removing excess acyl carnitine groups. Patients receiving chronic intermittent hemodialysis (HD) are known to be at increased risk for carnitine deficiency as a result of its removal during the dialysis procedure, lack of endogenous synthesis by the kidney, and inadequate dietary intake. The carnitine status of children undergoing continuous renal replacement therapy (CRRT) has not been studied. Children undergoing CRRT in the intensive care unit (ICU) setting may be at increased risk for carnitine deficiency due to its continuous removal, lack of carnitine production by the kidney, and absence of carnitine intake (as majority of these children can not eat and there is no carnitine added to total parenteral nutrition (TPN). Carnitine deficiency may increase the risk of cardiac dysfunction in critically ill children. This is the first study to examine carnitine status in children undergoing CRRT. Standard echo as well as more sensitive speckle tracking echo will be used to evaluate the effect of carnitine deficiency on myocardial function.
Detailed description
Study Design:The research design consists of a prospective study group that would be compared to two control groups (a prospective control groups and a retrospective control group). The study group will consist of critically ill children receiving CRRT and IV carnitine supplementation (added in the TPN). The prospective control group will consist of critically ill children not receiving CRRT or carnitine Retrospective control group will consist of critically ill children who received CRRT but did not receive carnitine supplementation. . Subjects for the prospective study and control groups will be recruited from the pediatric intensive care unit (PICU) and the cardiac intensive care unit (CICU) at Children's National. Informed consent will be obtained from participants enrolled in the prospective study and control groups. Data for the retrospective control group will be obtained from the medical record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carnitine CRRT, prospective | – | –CRRT patients given carnitine in TPN as part of clinical protocol. Will evaluate total and free, carnitine and acylcarnitine profile as well as cardiac function by standard and speckle tracking echo weekly during CRRT. |
| CRRT Control, retrospective | – | –Retrospective control group, CRRT patients who did not receive carnitine supplementation during CRRT and had carnitine levels measured and echo performed during CRRT. |
| ICU Control (non-CRRT), prospective | – | –Critically ill ICU patients not receiving any exogenous carnitine, and not receiving CRRT, will have total and free carnitine and acylcarnitine profile measured weekly during CRRT. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and young adults, age 1-21 years Critically ill, receiving care in intensive care unit
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
Cardiac function of children receiving carnitine compared with controls during CRRT
Time frame: 1-3 weeks
Echocardiography parameters of children in the study group will be compared to those of the retrospective CRRT control group.
1 secondary outcome
Carnitine deficiency in children receiving CRRT
Time frame: Baseline
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 23 Jan 2020.
- Derived from this study: PubMed 26265013Sgambat K, Moudgil A. Carnitine deficiency in children receiving continuous renal replacement therapy. Hemodial Int. 2016 Jan;20(1):63-7. doi: 10.1111/hdi.12341. Epub 2015 Aug 11.
- 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.
Asha Moudgil, MD principal investigator
Children's National Research Institute
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 Acute Renal Failure, run by Asha Moudgil 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?
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 23 Jan 2020. 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?
Cardiac function of children receiving carnitine compared with controls during CRRT (time frame: 1-3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01941823, which also lists 1 linked publication.
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 23 Jan 2020; AzTrials last refreshed its copy on 26 Oct 2026.