Carnitine, Aclycarnitine, Myocardial Function, and CRRT

NCT ID: NCT01941823

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2019-10-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. age 1-21 years

2. Receiving CRRT in the PICU or CICU

1. Children on chronic dialysis

2. Children on carnitine supplementation for a metabolic disorder

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)

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

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asha Moudgil

OTHER

Sponsor Role: lead

Responsible Party

Asha Moudgil

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Asha Moudgil, MD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

Children's National Medical Cetner

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26265013 (View on PubMed)

Other Identifiers

00003555

Identifier Type: -

Identifier Source: org_study_id