Carnitine, Aclycarnitine, Myocardial Function, & CRRT

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01941823
Study type	Observational
Source	Children's Research Institute
Contact
Status	Completed
Phase
Start date	December 2014
Completion date	October 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Carnitine, Aclycarnitine, Myocardial Function, and CRRT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms