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Carnitine, Aclycarnitine, Myocardial Function, and CRRT

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ClinicalTrials.gov Identifier: NCT01941823
Recruitment Status : Recruiting
First Posted : September 13, 2013
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Asha Moudgil, Children's Research Institute

Brief 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. 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.

Condition or disease
Acute Renal Failure

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study: Effect of Carnitine Supplementation on Acylcarnitine Profile and Myocardial Function in Children and Young Adults Receiving Continuous Renal Replacement Therapy
Study Start Date : December 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Carnitine deficiency in children receiving CRRT [ Time Frame: Baseline ]
    Total and free carnitine levels and acylcarnitine profile of the 3 study cohorts will be compared with published normal levels in children.



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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children and young adults, age 1-21 years Critically ill, receiving care in intensive care unit
Criteria

Patients

CRRT Study Group (n=10) Inclusion Criteria

  1. age 1-21 years
  2. Receiving CRRT in the PICU or CICU
  3. NPO or TPN-dependent Exclusion Criteria

1. 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

  1. Children on chronic dialysis
  2. Children on carnitine supplementation for a metabolic disorder

Retrospective CRRT Control Group (n=10) Inclusion Criteria

  1. 1-21years of age
  2. Received CRRT between 2011-2015
  3. Had total and free carnitine level checked while on CRRT (2 values>1 week apart)
  4. Had echocardiogram (2 studies >1 week apart) Exclusion Criteria

1. Receiving supplemental carnitine at time of carnitine level and/or echocardiogram 2. Congenital or acute heart disease 3. On ECMO


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941823


Contacts
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Contact: Asha Moudgil, MD amoudgil@cnmc.org
Contact: Kristen Sgambat, MS RD ksgambat@cnmc.org

Locations
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United States, District of Columbia
Children's National Medical Cetner Recruiting
Washington, District of Columbia, United States, 20010
Contact: Asha Moudgil, MD       amoudgil@cnmc.org   
Principal Investigator: Asha Moudgil, MD         
Sponsors and Collaborators
Asha Moudgil
Investigators
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Principal Investigator: Asha Moudgil, MD Children's Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Asha Moudgil, MD, Children's Research Institute
ClinicalTrials.gov Identifier: NCT01941823     History of Changes
Other Study ID Numbers: 00003555
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Asha Moudgil, Children's Research Institute:
acute renal failure
CRRT
continuous dialysis
carnitine
cardiac strain

Additional relevant MeSH terms:
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Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases