Evaluation of Status of Early Reached Target Enteral Nutrition and IFABP as Biomarker of Feeding Intolerance in Critically Ill Children

NCT02598375 | Unknown DMC

• 1 other identifier: ERTEN-IFABP IN PICU
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Stage 1 - Evaluation of Status of Early Reached Target Enteral Nutrition in critically ill children in the PICU (ERTEN in PICU). In critically ill children, there is no data on the factors influenced the enteral nutrition and feeding intolerance.The investigators aim to reach these goals in our study

• To initiate the enteral feeding in pediatric intensive care units or not
• To demonstrate the reasons whether early enteral feeding is initiated or not
• To determine the incidence of feeding intolerance
• To identify the situations such as analgesia ,sedation, catecholamines or individual preferences of the medical staff which lead to delay or interruption in enteral feeding in pediatric intensive care units
• To investigate the relation between the successful enteral feeding and mortality , morbidity du to the sepsis , septic shock and multiorgan failure Stage 2 - IFABP as biomarker of feeding intolerance in critically ill children in the PICU (IFABP in PICU) Critically ill children are at increased risk for intestinal injury, gastrointestinal dysfunction and feeding intolerance, which are associated with delayed recovery and increased morbidity and mortality during their course in the pediatric intensive care unit. In critically ill children, there is little data on the factors influenced the enteral nutrition. We hypothesise that IFABP might be used as a biomarker which shows that the early intestinal damage due to these medications. Aim There is no information which shows that the role of the intestinal microcirculation problems and mucosal integrity on feeding intolerance in pediatric intensive care unit.We aim to reach these goals in our study
• To show the value of IFABP regarding the identifying feeding intolerance and early detection of enteral feeding intolerance
• To show the relation between the IFABP concentration and enteral feeding intolerance
• To show the relation between the mechanical ventilation settings , sedation , inotropic medications doses and IFABP concentration and feeding intolerance
• To show the relation between IFABP concentrations and mortality and morbidity due to the sepsis , septic shock and multi system organ failure Stage 1 (ERTEN in PICU) was completed . In many patients, initiation of feeding seems to be delayed without an evidence-based reason. ERTEN was achieved in 43 (25.3%) of 95 patients within 48 h after PICU admission. Patients with Early Initiation of Feeding were statistically significant more likely to have ERTEN. ERTEN was independent significant prognostic factors for survival (p\<0.001), with reached target enteral caloric intake on day 2 indicating improved survival.

Conditions

Enteral Nutrition; Feeding Intolerance; Intestinal Fatty Acid Binding Protein

Keywords

Early reached target enteral nutrition in PICU feeding intolerance IFABP

Outcome Measures

Primary Outcomes (1)

• IFABP

  IFABP level in urine will be evaluated in critically iil children in order to understand feeding intolerance and /or bacterial translocation

  10 days

Secondary Outcomes (3)

• Zonulin

  10 days

• 8-hydroxydeoxyguanosine

  10 days

• Claudin-3

  10 days

Study Arms (2)

Children with feeding intolerance

Critically ill children having with respiratory or catecholamine support in PICU have the feeding intolerance at least for12 hours or more.

Other: Feeding intolerance

Children without feeding intolerance

Critically ill children having with respiratory or catecholamine support in PICU have not the feeding intolerance signs at least for 12 hours or less

Other: Feeding intolerance

Interventions

Feeding intolerance OTHER

In this study ; it is aimed to show the value of IFABP regarding the identifying the feeding intolerance and early detection of enteral feeding intolerance

Children with feeding intolerance; Children without feeding intolerance

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The critically ill children in PICU who stay at least for 4 days

You may qualify if:

• critically iil children who stayed in PICU at least for 4 days
• having informed consent from the parents of patients

You may not qualify if:

• children with primary gastrointestinal problems ( ulcerative colitis ,crohn ,acute gastrointestinal bleeding )

Sponsors & Collaborators

• Gazi University: lead
• Cukurova University: collaborator
• Children's Medical Hospital, University of Bonn, Germany: collaborator
• Eskisehir Osmangazi University: collaborator
• Akdeniz University: collaborator
• TC Erciyes University: collaborator
• Hacettepe University: collaborator
• Dokuz Eylul University: collaborator
• Tepecik Training and Research Hospital: collaborator
• Marmara University: collaborator
• Ankara University: collaborator
• Zonguldak Bulent Ecevit University: collaborator
• Istanbul University: collaborator
• Istanbul Medipol University Hospital: collaborator
• Sisli Hamidiye Etfal Training and Research Hospital: collaborator
• Acibadem University: collaborator

Study Sites (1)

Bonn University Faculty of Medicine

Bonn, 53127, Germany

RECRUITING

Related Publications (12)

• Mehta NM, McAleer D, Hamilton S, Naples E, Leavitt K, Mitchell P, Duggan C. Challenges to optimal enteral nutrition in a multidisciplinary pediatric intensive care unit. JPEN J Parenter Enteral Nutr. 2010 Jan-Feb;34(1):38-45. doi: 10.1177/0148607109348065. Epub 2009 Nov 10.

  PMID: 19903872 RESULT

• Lopez-Herce J. Gastrointestinal complications in critically ill patients: what differs between adults and children? Curr Opin Clin Nutr Metab Care. 2009 Mar;12(2):180-5. doi: 10.1097/MCO.0b013e3283218285.

  PMID: 19202390 RESULT

• Pathan N, Burmester M, Adamovic T, Berk M, Ng KW, Betts H, Macrae D, Waddell S, Paul-Clark M, Nuamah R, Mein C, Levin M, Montana G, Mitchell JA. Intestinal injury and endotoxemia in children undergoing surgery for congenital heart disease. Am J Respir Crit Care Med. 2011 Dec 1;184(11):1261-9. doi: 10.1164/rccm.201104-0715OC. Epub 2011 Aug 25.

  PMID: 21868501 RESULT

• Mehta NM, Bechard LJ, Cahill N, Wang M, Day A, Duggan CP, Heyland DK. Nutritional practices and their relationship to clinical outcomes in critically ill children--an international multicenter cohort study*. Crit Care Med. 2012 Jul;40(7):2204-11. doi: 10.1097/CCM.0b013e31824e18a8.

  PMID: 22564954 RESULT

• Mehta NM, Compher C; A.S.P.E.N. Board of Directors. A.S.P.E.N. Clinical Guidelines: nutrition support of the critically ill child. JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):260-76. doi: 10.1177/0148607109333114. No abstract available.

  PMID: 19398612 RESULT

• Chellis MJ, Sanders SV, Webster H, Dean JM, Jackson D. Early enteral feeding in the pediatric intensive care unit. JPEN J Parenter Enteral Nutr. 1996 Jan-Feb;20(1):71-3. doi: 10.1177/014860719602000171.

  PMID: 8788267 RESULT

• Mikhailov TA, Kuhn EM, Manzi J, Christensen M, Collins M, Brown AM, Dechert R, Scanlon MC, Wakeham MK, Goday PS. Early enteral nutrition is associated with lower mortality in critically ill children. JPEN J Parenter Enteral Nutr. 2014 May;38(4):459-66. doi: 10.1177/0148607113517903. Epub 2014 Jan 8.

  PMID: 24403379 RESULT

• Aydemir C, Dilli D, Oguz SS, Ulu HO, Uras N, Erdeve O, Dilmen U. Serum intestinal fatty acid binding protein level for early diagnosis and prediction of severity of necrotizing enterocolitis. Early Hum Dev. 2011 Oct;87(10):659-61. doi: 10.1016/j.earlhumdev.2011.05.004. Epub 2011 Jun 8.

  PMID: 21641735 RESULT

• Reisinger KW, Van der Zee DC, Brouwers HA, Kramer BW, van Heurn LW, Buurman WA, Derikx JP. Noninvasive measurement of fecal calprotectin and serum amyloid A combined with intestinal fatty acid-binding protein in necrotizing enterocolitis. J Pediatr Surg. 2012 Sep;47(9):1640-5. doi: 10.1016/j.jpedsurg.2012.02.027.

  PMID: 22974599 RESULT

• Thuijls G, van Wijck K, Grootjans J, Derikx JP, van Bijnen AA, Heineman E, Dejong CH, Buurman WA, Poeze M. Early diagnosis of intestinal ischemia using urinary and plasma fatty acid binding proteins. Ann Surg. 2011 Feb;253(2):303-8. doi: 10.1097/SLA.0b013e318207a767.

  PMID: 21245670 RESULT

• van Haren FM, Pickkers P, Foudraine N, Heemskerk S, Sleigh J, van der Hoeven JG. The effects of methylene blue infusion on gastric tonometry and intestinal fatty acid binding protein levels in septic shock patients. J Crit Care. 2010 Jun;25(2):358.e1-7. doi: 10.1016/j.jcrc.2010.02.008. Epub 2010 Apr 8.

  PMID: 20381302 RESULT

• Piton G, Belon F, Cypriani B, Regnard J, Puyraveau M, Manzon C, Navellou JC, Capellier G. Enterocyte damage in critically ill patients is associated with shock condition and 28-day mortality. Crit Care Med. 2013 Sep;41(9):2169-76. doi: 10.1097/CCM.0b013e31828c26b5.

  PMID: 23782971 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and blood will be collected from critically ill children in PICU

Study Officials

• Dincer Yildizdas, 3

  Çukurova University Faculty of Medicine

  STUDY CHAIR

• Soyhan Bagcı, 2

  Bonn University Faculty of Medicine

  STUDY DIRECTOR

Central Study Contacts

Elif Keles, 1

CONTACT

00905366741270; elifkeles.dr@gmail.com

Soyhan Bagci, 2

CONTACT

004915158233102; soyhan.bagci@ukb.uni-bonn.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD ,Resident Physician in Pediatrics

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 5, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: December 28, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)