Carnitine, Aclycarnitine, Myocardial Function, and CRRT

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.

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Key information

Conditions

Acute Renal Failure Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Medical Cetner

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Asha Moudgil

Other

Registry information

Official study title

Pilot Study: Effect of Carnitine Supplementation on Acylcarnitine Profile and Myocardial Function in Children and Young Adults Receiving Continuous Renal Replacement Therapy

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2019
First posted: Sep 13, 2013
Registry last updated: Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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