Carnitine, Aclycarnitine, Myocardial Function, and CRRT

NCT01941823 | Completed

• 1 other identifier: 00003555
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Failure

Keywords

acute renal failure; CRRT; continuous dialysis; carnitine; cardiac strain

Outcome Measures

Primary Outcomes (1)

• 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.

  1-3 weeks

Secondary Outcomes (1)

• Carnitine deficiency in children receiving CRRT

  Baseline

Study Arms (3)

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.

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children and young adults, age 1-21 years Critically ill, receiving care in intensive care unit

You may qualify if:

• age 1-21 years
• Receiving CRRT in the PICU or CICU

You may not qualify if:

• \. Children on chronic dialysis 4. Children on carnitine supplementation for a metabolic disorder 5. Children on CRRT for less than 1 week
• Children on chronic dialysis
• Children on carnitine supplementation for a metabolic disorder
• years of age
• Received CRRT between 2011-2015
• Had total and free carnitine level checked while on CRRT (2 values\>1 week apart)
• \. Receiving supplemental carnitine at time of carnitine level and/or echocardiogram 2. Congenital or acute heart disease 3. On ECMO

Sponsors & Collaborators

• Asha Moudgil: lead

Study Sites (1)

Children's National Medical Cetner

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

Location

Related Publications (1)

• 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.

  PMID: 26265013 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Asha Moudgil, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 13, 2013
• Study Start: December 1, 2014
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)