Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-03-04 @ 10:42 PM
Study NCT ID:
NCT02409706
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2015-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Micronutrients in Children in Critical Care With Cardiac Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood Plasma Red blood cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-15', 'studyFirstSubmitDate': '2015-03-27', 'studyFirstSubmitQcDate': '2015-04-06', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Micronutrient Status', 'timeFrame': 'Pre- and post- operative: 24-48 hours', 'description': 'Micronutrient concentrations in plasma and erythrocytes'}], 'secondaryOutcomes': [{'measure': 'Postoperative LOS', 'timeFrame': '1 year', 'description': 'Length of hospital stay'}, {'measure': 'Postoperative Infectious complications', 'timeFrame': '1 year', 'description': 'Incidence of infections'}, {'measure': 'Postoperative ventilator time', 'timeFrame': '1 year', 'description': 'Duration of ventilation'}, {'measure': 'Postoperative LICU', 'timeFrame': '1 year', 'description': 'Length of stay in PICU'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Paediatric', 'Critical care', 'Micronutrients'], 'conditions': ['Heart Defects, Congenital']}, 'referencesModule': {'references': [{'pmid': '20824455', 'type': 'BACKGROUND', 'citation': 'Dolk H, Loane M, Garne E. The prevalence of congenital anomalies in Europe. Adv Exp Med Biol. 2010;686:349-64. doi: 10.1007/978-90-481-9485-8_20.'}, {'pmid': '21045784', 'type': 'BACKGROUND', 'citation': 'van der Bom T, Zomer AC, Zwinderman AH, Meijboom FJ, Bouma BJ, Mulder BJ. The changing epidemiology of congenital heart disease. Nat Rev Cardiol. 2011 Jan;8(1):50-60. doi: 10.1038/nrcardio.2010.166. Epub 2010 Nov 2.'}, {'pmid': '18000517', 'type': 'BACKGROUND', 'citation': 'Nydegger A, Walsh A, Penny DJ, Henning R, Bines JE. Changes in resting energy expenditure in children with congenital heart disease. Eur J Clin Nutr. 2009 Mar;63(3):392-7. doi: 10.1038/sj.ejcn.1602956. Epub 2007 Nov 14.'}, {'pmid': '7727190', 'type': 'BACKGROUND', 'citation': 'Mitchell IM, Logan RW, Pollock JC, Jamieson MP. Nutritional status of children with congenital heart disease. Br Heart J. 1995 Mar;73(3):277-83. doi: 10.1136/hrt.73.3.277.'}, {'pmid': '18377449', 'type': 'BACKGROUND', 'citation': 'Kogon BE, Ramaswamy V, Todd K, Plattner C, Kirshbom PM, Kanter KR, Simsic J. Feeding difficulty in newborns following congenital heart surgery. Congenit Heart Dis. 2007 Sep-Oct;2(5):332-7. doi: 10.1111/j.1747-0803.2007.00121.x.'}, {'pmid': '16607132', 'type': 'BACKGROUND', 'citation': 'Hulst JM, Joosten KF, Tibboel D, van Goudoever JB. Causes and consequences of inadequate substrate supply to pediatric ICU patients. Curr Opin Clin Nutr Metab Care. 2006 May;9(3):297-303. doi: 10.1097/01.mco.0000222115.91783.71.'}, {'type': 'BACKGROUND', 'citation': 'Bird J, Gentles E, Diamantidi K, Spenceley N, Gerasimidis K. Nutritional intake in a cardiac PICU improved following the introduction of enteral nutrition guidelines. Journal of American Dietetic Association 2013'}, {'type': 'BACKGROUND', 'citation': 'Bird J, Gentles E, Diamantidi K, Alfheeaid H, MacLeod I, Ellis D, Spenceley N, Davidson M, Gerasimidis K. Micronutrient intake in a mixed speciality paediatric intensive care unit. World Congress of Paediatric Intensive Care 2011'}, {'type': 'BACKGROUND', 'citation': 'Gentles E, Bird J, Davidson M, Spenceley N, Ellis D and Macleod I. The impact of fasting, fluid restriction and slow initiation and advancement of enteral feeds on daily energy intake in PICU. Paediatric Intenstive Care Society Annual Conference 2010'}, {'pmid': '11448572', 'type': 'BACKGROUND', 'citation': 'Briassoulis G, Zavras N, Hatzis T. Malnutrition, nutritional indices, and early enteral feeding in critically ill children. Nutrition. 2001 Jul-Aug;17(7-8):548-57. doi: 10.1016/s0899-9007(01)00578-0.'}, {'pmid': '19581268', 'type': 'BACKGROUND', 'citation': 'Vaidyanathan B, Radhakrishnan R, Sarala DA, Sundaram KR, Kumar RK. What determines nutritional recovery in malnourished children after correction of congenital heart defects? Pediatrics. 2009 Aug;124(2):e294-9. doi: 10.1542/peds.2009-0141. Epub 2009 Jul 5.'}, {'pmid': '21514216', 'type': 'BACKGROUND', 'citation': 'Padley JR, Cole AD, Pye VE, Chard RB, Nicholson IA, Jacobe S, Baines D, Badawi N, Walker K, Scarfe G, Leclair K, Sholler GF, Winlaw DS. Five-year analysis of operative mortality and neonatal outcomes in congenital heart disease. Heart Lung Circ. 2011 Jul;20(7):460-7. doi: 10.1016/j.hlc.2011.03.009. Epub 2011 Apr 21.'}, {'pmid': '21481081', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20655701', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21460705', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21445641', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15380899', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '16182038', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '16054730', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '18614734', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '19698706', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '20667447', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '21411617', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '12600973', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '22069243', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '21958977', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '23708640', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18037540', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '22158726', 'type': 'BACKGROUND', 'citation': "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': '20398432', 'type': 'BACKGROUND', 'citation': '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': '23145520', 'type': 'BACKGROUND', 'citation': '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': '23391458', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Congenital heart disease (CHD) is one of the most common birth defects in the UK. Children with CHD are at risk of underfeeding and undernutrition. This is due to both the increased nutritional requirements of the disease and sometimes clinical management, which often hinders delivery of optimal nutrition.There are as yet no studies assessing micronutrient body stores in children with CHD or whether micronutrient deficiencies predict poor clinical outcomes, such as post-operative complications, after major cardiac operations.\n\nThis study aims to explore the frequency, types and associations of micronutrient deficiencies in 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with congenital heart defects who are admitted for elective cardiac surgery at the Royal Hospital for Sick Children, Glasgow.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infant or child admitted for elective congenital cardiac surgery at the Royal Hospital for Sick Children, Glasgow.\n* Aged less than 5 years old\n\nExclusion Criteria:\n\n* Infant or child admitted for emergency cardiac surgery\n* Infant or child whose carer with parental responsibility is unable to communicate in English'}, 'identificationModule': {'nctId': 'NCT02409706', 'acronym': 'MC5', 'briefTitle': 'Micronutrients in Children in Critical Care With Cardiac Conditions', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'Micronutrient Deficiencies in Children and Infants With Congenital Heart Diseases (CHD) Admitted for Cardiac Surgery: A Proof-of-concept Study', 'orgStudyIdInfo': {'id': 'GN14KH356'}, 'secondaryIdInfos': [{'id': 'GN14KH356', 'type': 'OTHER', 'domain': 'NHS Greater Glasgow and Clyde'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G3 8SJ', 'city': 'Glasgow', 'state': 'Glasgow City', 'country': 'United Kingdom', 'facility': 'Royal Hospital for Sick Children', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Neil Spenceley, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Hospital for Sick Children, Glasgow'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Glasgow', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}