Micronutrients in Children in Critical Care With Cardiac Conditions

NCT02409706 | Completed

• 1 other identifier: GN14KH356
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the frequency and types of micronutrient deficiencies in a sample of UK children with CHD using standard and novel markers in blood. The study will also explore whether micronutrient deficiencies increase the risk of complications after heart surgery. This study will identify any nutrient deficiencies that need monitoring in clinical practice.

Conditions

Heart Defects, Congenital

Keywords

Paediatric; Critical care; Micronutrients

Outcome Measures

Primary Outcomes (1)

• Micronutrient Status

  Micronutrient concentrations in plasma and erythrocytes

  Pre- and post- operative: 24-48 hours

Secondary Outcomes (4)

• Postoperative LOS

  1 year

• Postoperative Infectious complications

  1 year

• Postoperative ventilator time

  1 year

• Postoperative LICU

  1 year

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with congenital heart defects who are admitted for elective cardiac surgery at the Royal Hospital for Sick Children, Glasgow.

You may qualify if:

• Infant or child admitted for elective congenital cardiac surgery at the Royal Hospital for Sick Children, Glasgow.
• Aged less than 5 years old

You may not qualify if:

• Infant or child admitted for emergency cardiac surgery
• Infant or child whose carer with parental responsibility is unable to communicate in English

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

Royal Hospital for Sick Children

Glasgow, Glasgow City, G3 8SJ, United Kingdom

Location

Related Publications (32)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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• Thiagarajan RR, Laussen PC. Mortality as an outcome measure following cardiac surgery for congenital heart disease in the current era. Paediatr Anaesth. 2011 May;21(5):604-8. doi: 10.1111/j.1460-9592.2011.03580.x.

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• Cander B, Dundar ZD, Gul M, Girisgin S. Prognostic value of serum zinc levels in critically ill patients. J Crit Care. 2011 Feb;26(1):42-6. doi: 10.1016/j.jcrc.2010.06.002. Epub 2010 Jul 23.

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• Stoppe C, Schalte G, Rossaint R, Coburn M, Graf B, Spillner J, Marx G, Rex S. The intraoperative decrease of selenium is associated with the postoperative development of multiorgan dysfunction in cardiac surgical patients. Crit Care Med. 2011 Aug;39(8):1879-85. doi: 10.1097/CCM.0b013e3182190d48.

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• Manzanares W, Biestro A, Torre MH, Galusso F, Facchin G, Hardy G. High-dose selenium reduces ventilator-associated pneumonia and illness severity in critically ill patients with systemic inflammation. Intensive Care Med. 2011 Jul;37(7):1120-7. doi: 10.1007/s00134-011-2212-6. Epub 2011 Mar 29.

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• Gray A, McMillan DC, Wilson C, Williamson C, O'Reilly DS, Talwar D. The relationship between plasma and red cell concentrations of vitamins thiamine diphosphate, flavin adenine dinucleotide and pyridoxal 5-phosphate following elective knee arthroplasty. Clin Nutr. 2004 Oct;23(5):1080-3. doi: 10.1016/j.clnu.2004.01.013.

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• Gray A, McMillan DC, Wilson C, Williamson C, O'Reilly DS, Talwar D. The relationship between the acute changes in the systemic inflammatory response, lipid soluble antioxidant vitamins and lipid peroxidation following elective knee arthroplasty. Clin Nutr. 2005 Oct;24(5):746-50. doi: 10.1016/j.clnu.2005.02.008. Epub 2005 Apr 8.

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• Quasim T, McMillan DC, Talwar D, Vasilaki A, St J O'Reilly D, Kinsella J. The relationship between plasma and red cell B-vitamin concentrations in critically-ill patients. Clin Nutr. 2005 Dec;24(6):956-60. doi: 10.1016/j.clnu.2005.06.004. Epub 2005 Jul 28.

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• Vasilaki AT, McMillan DC, Kinsella J, Duncan A, O'Reilly DS, Talwar D. Relation between pyridoxal and pyridoxal phosphate concentrations in plasma, red cells, and white cells in patients with critical illness. Am J Clin Nutr. 2008 Jul;88(1):140-6. doi: 10.1093/ajcn/88.1.140.

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• Vasilaki AT, Leivaditi D, Talwar D, Kinsella J, Duncan A, O'Reilly DS, McMillan DC. Assessment of vitamin E status in patients with systemic inflammatory response syndrome: plasma, plasma corrected for lipids or red blood cell measurements? Clin Chim Acta. 2009 Nov;409(1-2):41-5. doi: 10.1016/j.cca.2009.08.008. Epub 2009 Aug 19.

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• Vasilaki AT, McMillan DC, Kinsella J, Duncan A, O'Reilly DS, Talwar D. Relation between riboflavin, flavin mononucleotide and flavin adenine dinucleotide concentrations in plasma and red cells in patients with critical illness. Clin Chim Acta. 2010 Nov 11;411(21-22):1750-5. doi: 10.1016/j.cca.2010.07.024. Epub 2010 Jul 24.

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• Reid D, Toole BJ, Knox S, Talwar D, Harten J, O'Reilly DS, Blackwell S, Kinsella J, McMillan DC, Wallace AM. The relation between acute changes in the systemic inflammatory response and plasma 25-hydroxyvitamin D concentrations after elective knee arthroplasty. Am J Clin Nutr. 2011 May;93(5):1006-11. doi: 10.3945/ajcn.110.008490. Epub 2011 Mar 16.

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• Talwar D, Quasim T, McMillan DC, Kinsella J, Williamson C, O'Reilly DS. Pyridoxal phosphate decreases in plasma but not erythrocytes during systemic inflammatory response. Clin Chem. 2003 Mar;49(3):515-8. doi: 10.1373/49.3.515. No abstract available.

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• Gerasimidis K, Talwar D, Duncan A, Moyes P, Buchanan E, Hassan K, O'Reilly D, McGrogan P, Edwards CA. Impact of exclusive enteral nutrition on body composition and circulating micronutrients in plasma and erythrocytes of children with active Crohn's disease. Inflamm Bowel Dis. 2012 Sep;18(9):1672-81. doi: 10.1002/ibd.21916. Epub 2011 Nov 8.

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• Duncan A, Dean P, Simm M, O'Reilly DS, Kinsella J. Zinc supplementation in intensive care: results of a UK survey. J Crit Care. 2012 Feb;27(1):102.e1-6. doi: 10.1016/j.jcrc.2011.07.083. Epub 2011 Sep 29.

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• Gerasimidis K, Edwards C, Stefanowicz F, Galloway P, McGrogan P, Duncan A, Talwar D. Micronutrient status in children with IBD: true deficiencies or epiphenomenon of the systemic inflammatory response. J Pediatr Gastroenterol Nutr. 2013 Jun;56(6):e50-1. doi: 10.1097/MPG.0b013e31828f1e86. No abstract available.

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• Oakes EJ, Lyon TD, Duncan A, Gray A, Talwar D, O'Reilly DS. Acute inflammatory response does not affect erythrocyte concentrations of copper, zinc and selenium. Clin Nutr. 2008 Feb;27(1):115-20. doi: 10.1016/j.clnu.2007.10.003. Epub 2007 Nov 26.

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• Duncan A, Talwar D, McMillan DC, Stefanowicz F, O'Reilly DS. Quantitative data on the magnitude of the systemic inflammatory response and its effect on micronutrient status based on plasma measurements. Am J Clin Nutr. 2012 Jan;95(1):64-71. doi: 10.3945/ajcn.111.023812. Epub 2011 Dec 7.

  PMID: 22158726 BACKGROUND

• Gerasimidis K, Keane O, Macleod I, Flynn DM, Wright CM. A four-stage evaluation of the Paediatric Yorkhill Malnutrition Score in a tertiary paediatric hospital and a district general hospital. Br J Nutr. 2010 Sep;104(5):751-6. doi: 10.1017/S0007114510001121. Epub 2010 Apr 19.

  PMID: 20398432 BACKGROUND

• Gerasimidis K, Macleod I, Finlayson L, McGuckin C, Wright C, Flynn D, McGrogan P, Maclean A, Love E, Swinbank I, Mohammed T, McAuley M. Introduction of Paediatric Yorkhill Malnutrition Score--challenges and impact on nursing practice. J Clin Nurs. 2012 Dec;21(23-24):3583-6. doi: 10.1111/j.1365-2702.2012.04164.x. No abstract available.

  PMID: 23145520 BACKGROUND

• Stefanowicz FA, Talwar D, O'Reilly DS, Dickinson N, Atkinson J, Hursthouse AS, Rankin J, Duncan A. Erythrocyte selenium concentration as a marker of selenium status. Clin Nutr. 2013 Oct;32(5):837-42. doi: 10.1016/j.clnu.2013.01.005. Epub 2013 Jan 16.

  PMID: 23391458 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood Plasma Red blood cells

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Neil Spenceley, MBChB

  Royal Hospital for Sick Children, Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 7, 2015
• Study Start: August 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 16, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)