Evaluation of Nutritional Practices in the Critical Care
ENPIC
1 other identifier
observational
642
1 country
43
Brief Summary
Background: The adequacy of the artificial Nutritional Support (NS) in the critical care patient has implications in morbidity and prognosis. Clinical practice guidelines (CPG) are an important tool for healthcare professionals in their daily practice and a method of consultation for the correct treatment of patients. Also, the evidence remains low and there are important controversies regarding the NS in the critical care patient. Hypothesis: The NS generates great controversy in the professionals involved in the care of critical care patients due to the contradictory results in literature. Despite this, the CPG should serve to standardize the treatment of patients and provide a better adherence to current knowledge in this setting. The importance of NS is underestimated and there is a need to perform proper evaluation of the impact of nutrition. Objectives: To evaluate and analyze NS practices in critically ill patients in different ICUs and assess the adherence to CPGs. To evaluate the relationship of nutrition and outcomes in the ICU. Methodology: Prospective multicenter observational study. Collection of variables from different participating ICUs and the characteristics of the NS of the different admitted patients. Monitoring of nutritional practices and complications. Evaluation of outcomes (e.g. mortality, ICU complications, etc.) with NS. Expected results: Better understanding of the NS and its impact on morbidity and mortality; development of strategies to reduce low adherence to CPGs, improving the quality of care associated with this field in critical care patients; obtain clinical information that will serve as a basis for conducting intervention studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Longer than P75 for all trials
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2018
CompletedFirst Submitted
Initial submission to the registry
August 12, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2022
CompletedMarch 23, 2022
March 1, 2022
5 months
August 12, 2018
March 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Kilocalories delivered by enteral and/or parenteral route and Energy balance
Kilocalories delivered by nutritional support - (minus) nutritional support target in Kilocalories
Daily to a maximum of 14 days after Intensive Care Unit Admission
gram of proteins delivered by enteral and/or parenteral route
Proteins delivered by nutritional support - (minus) nutritional support target in gram of proteins
Daily to a maximum of 14 days after Intensive Care Unit Admission
Rate of complications related with nutritional support (Enteral and/or Parenteral route)
Main artificial nutritional support serious complications (i.e. constipation, higher residual gastric volume, vomiting, diarrhea associated with enteral nutrition, meseteric ischemia) requiring a therapeutical intervention or modification of the nutritional support - safety related variable
Daily to a maximum of 14 days after Intensive Care Unit Admission
Rate of 28-day mortality associated with the characteristics of nutritional support (e.g., gram of proteins, etc.)
Influence of nutritional support or any nutrition-related variable on mortality during ICU admission
Daily to a maximum of 28 days after Intensive Care Unit Admission
Secondary Outcomes (3)
Time from Intensive Care Unit admission to the start of enteral nutrition
Up to 120 hours after Intensive Care Unit Admission
Dose of vasoactive drugs
Daily to a maximum of 14 days after Intensive Care Unit Admission
Glycaemic control
Daily to a maximum of 14 days after Intensive Care Unit Admission
Study Arms (1)
Patients with Nutritional Support
Patients expected to be admitted \>72h at the Intensive Care Unit with the need of artificial Nutritional Support
Interventions
Evaluation of Enteral Nutrition or Parenteral Nutrition or both administered to the patients needing artificial Nutritional Support
Eligibility Criteria
Adult Critical Care patients needing Artificial Nutritional Support
You may qualify if:
- Age \>18 years old.
- Need of ICU admission \>72h.
- Need of Artificial Nutrional Support (Enteral Nutrition or Parenteral Nutrition or both).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Universitari de Bellvitgelead
- Hospital Arnau de Vilanovacollaborator
- Hospital Universitario 12 de Octubrecollaborator
Study Sites (43)
Hospital Sant Joan d' Alacant
Sant Joan d'Alacant, Alicante, 03550, Spain
H. Manacor
Manacor, Balearic Islands, 07500, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
H. General de Granollers
Granollers, Barcelona, 08402, Spain
Hospital Universitari de Bellvitge (Cardiology Unit)
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital de Mataró
Mataró, Barcelona, 08304, Spain
Hospital Mutua Terrasa.
Terrassa, Barcelona, 08221, Spain
Hospital General Universitario de Castellón
Castellon, Castellón, 12004, Spain
Hospital Universitario de Puerto Real
Puerto Real, Cádiz, 11510, Spain
Hospital de Barbastro
Barbastro, Huesca, 22300, Spain
Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, 28805, Spain
Hospital Quirón Sur
Alcorcón, Madrid, 28922, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
Hospital Universitario de Getafe
Getafe, Madrid, 28905, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911, Spain
Hospital Infanta Cristina
Parla, Madrid, 28981, Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, 28703, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36312, Spain
Hospital Universitario de A Coruña
A Coruña, 15006, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Plató
Barcelona, 08006, Spain
Hospital de la Santa Creu i Sant Pau.
Barcelona, 08041, Spain
Hospital Universitario de Burgos
Burgos, 09006, Spain
Hospital Universitari Josep Trueta
Girona, 17007, Spain
Hospital General San Jorge
Huesca, 22004, Spain
Hospital Universitari Arnau de Vilanova
Lleida, 25198, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario 12 de Octubre (Trauma Unit)
Madrid, Spain
Hospital Regional Universitario Carlos Haya
Málaga, 29010, Spain
Hospital General Universitario Reina Sofia
Murcia, 30003, Spain
Hosptial General Universitario Morales Meseguer
Murcia, 30008, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitari Doctor Peset
Valencia, 46017, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47003, Spain
Hospital Rio Hortega
Valladolid, 47012, Spain
Hospital Virgen de la Concha
Zamora, 49022, Spain
Hospital Clínico Lozano Blesa
Zaragoza, 50009, Spain
Hospital Miguel Servet
Zaragoza, 50009, Spain
Hospital Royo Villanova
Zaragoza, 50015, Spain
Related Publications (15)
Marik PE, Zaloga GP. Early enteral nutrition in acutely ill patients: a systematic review. Crit Care Med. 2001 Dec;29(12):2264-70. doi: 10.1097/00003246-200112000-00005.
PMID: 11801821RESULTHeyland D, Cook DJ, Winder B, Brylowski L, Van deMark H, Guyatt G. Enteral nutrition in the critically ill patient: a prospective survey. Crit Care Med. 1995 Jun;23(6):1055-60. doi: 10.1097/00003246-199506000-00010.
PMID: 7774216RESULTCorreia MI, Waitzberg DL. The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through a multivariate model analysis. Clin Nutr. 2003 Jun;22(3):235-9. doi: 10.1016/s0261-5614(02)00215-7.
PMID: 12765661RESULTDvir D, Cohen J, Singer P. Computerized energy balance and complications in critically ill patients: an observational study. Clin Nutr. 2006 Feb;25(1):37-44. doi: 10.1016/j.clnu.2005.10.010.
PMID: 16321459RESULTDeitch EA. Role of the gut lymphatic system in multiple organ failure. Curr Opin Crit Care. 2001 Apr;7(2):92-8. doi: 10.1097/00075198-200104000-00007.
PMID: 11373517RESULTHarvey SE, Parrott F, Harrison DA, Bear DE, Segaran E, Beale R, Bellingan G, Leonard R, Mythen MG, Rowan KM; CALORIES Trial Investigators. Trial of the route of early nutritional support in critically ill adults. N Engl J Med. 2014 Oct 30;371(18):1673-84. doi: 10.1056/NEJMoa1409860. Epub 2014 Oct 1.
PMID: 25271389RESULTPatel JJ, Codner P. Controversies in Critical Care Nutrition Support. Crit Care Clin. 2016 Apr;32(2):173-89. doi: 10.1016/j.ccc.2015.11.002. Epub 2016 Feb 4.
PMID: 27016160RESULTArtinian V, Krayem H, DiGiovine B. Effects of early enteral feeding on the outcome of critically ill mechanically ventilated medical patients. Chest. 2006 Apr;129(4):960-7. doi: 10.1378/chest.129.4.960.
PMID: 16608945RESULTFlordelis Lasierra JL, Perez-Vela JL, Montejo Gonzalez JC. Enteral nutrition in the hemodynamically unstable critically ill patient. Med Intensiva. 2015 Jan-Feb;39(1):40-8. doi: 10.1016/j.medin.2014.04.002. Epub 2014 Jun 4. English, Spanish.
PMID: 24907000RESULTArabi YM, Aldawood AS, Haddad SH, Al-Dorzi HM, Tamim HM, Jones G, Mehta S, McIntyre L, Solaiman O, Sakkijha MH, Sadat M, Afesh L; PermiT Trial Group. Permissive Underfeeding or Standard Enteral Feeding in Critically Ill Adults. N Engl J Med. 2015 Jun 18;372(25):2398-408. doi: 10.1056/NEJMoa1502826. Epub 2015 May 20. Erratum In: N Engl J Med. 2015 Sep 24;373(13):1281. doi: 10.1056/NEJMx150028.
PMID: 25992505RESULTNational Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.
PMID: 22307571RESULTWischmeyer PE. Are we creating survivors...or victims in critical care? Delivering targeted nutrition to improve outcomes. Curr Opin Crit Care. 2016 Aug;22(4):279-84. doi: 10.1097/MCC.0000000000000332. No abstract available.
PMID: 27327244RESULTWei X, Day AG, Ouellette-Kuntz H, Heyland DK. The Association Between Nutritional Adequacy and Long-Term Outcomes in Critically Ill Patients Requiring Prolonged Mechanical Ventilation: A Multicenter Cohort Study. Crit Care Med. 2015 Aug;43(8):1569-79. doi: 10.1097/CCM.0000000000001000.
PMID: 25855901RESULTLopez-Delgado JC, Servia-Goixart L, Grau-Carmona T, Bordeje-Laguna L, Portugal-Rodriguez E, Lorencio-Cardenas C, Vera-Artazcoz P, Macaya-Redin L, Martinez-Carmona JF, Marin Corral J, Flordelis-Lasierra JL, Seron-Arbeloa C, Alcazar-Espin MLN, Navas-Moya E, Aldunate-Calvo S, Nieto Martino B, Martinez de Lagran I. Factors associated with the need of parenteral nutrition in critically ill patients after the initiation of enteral nutrition therapy. Front Nutr. 2023 Aug 24;10:1250305. doi: 10.3389/fnut.2023.1250305. eCollection 2023.
PMID: 37693244DERIVEDServia-Goixart L, Lopez-Delgado JC, Grau-Carmona T, Trujillano-Cabello J, Bordeje-Laguna ML, Mor-Marco E, Portugal-Rodriguez E, Lorencio-Cardenas C, Montejo-Gonzalez JC, Vera-Artazcoz P, Macaya-Redin L, Martinez-Carmona JF, Iglesias-Rodriguez R, Monge-Donaire D, Flordelis-Lasierra JL, Llorente-Ruiz B, Menor-Fernandez EM, Martinez de Lagran I, Yebenes-Reyes JC; ENPIC Study Investigators. Evaluation of Nutritional Practices in the Critical Care patient (The ENPIC study): Does nutrition really affect ICU mortality? Clin Nutr ESPEN. 2022 Feb;47:325-332. doi: 10.1016/j.clnesp.2021.11.018. Epub 2021 Nov 16.
PMID: 35063222DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Teodoro Grau-Carmona, Ph.D.
Hospital 12 de Octubre
- PRINCIPAL INVESTIGATOR
Lluís Servia-Goixart, Ph.D.
Hospital Arnau de Vilanova / Biomedical Research Institute of Lleida (IRBLleida) Institut de Recerca Biomèdica de Lleida
- PRINCIPAL INVESTIGATOR
Juan Carlos Lopez-Delgado, Ph.D
Hospital Universitari de Bellvitge
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Intensive Care Specialist
Study Record Dates
First Submitted
August 12, 2018
First Posted
August 17, 2018
Study Start
April 23, 2018
Primary Completion
September 15, 2018
Study Completion
March 22, 2022
Last Updated
March 23, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share
Data will be analyzed by the principal investigators of each participating hospital. Share IPD is not allowed in the present study to other researchers.