Evaluation of Nutritional Practices in the Critical Care
NCT ID: NCT03634943
Last Updated: 2022-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
642 participants
OBSERVATIONAL
2018-04-23
2022-03-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trophic Nutrition in Patients Submitted to High Flow Oxygen Therapy and / or Non Invasive Mechanical Ventilation
NCT03728452
Nutrition Under Noninvasive Ventilation
NCT06260202
Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients (NutriPhyT Trial)
NCT05865314
Respiratory Care in Intensive Care Unit for Neuromuscular Patients
NCT02936908
ICU Nutrition Study Bern
NCT00574431
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All the complications described associated with the artificial Nutritional support and others related to the critical patient will be evaluated daily by the research team and reflected in the electronic data collection form (eCRF).
The eCRF has been carried out through the REDCAP ™ platform and designed by the Department of Information Technology of Lleida of the Universitari Arnau de Vilanova Hospital, under the supervision of Dr. Lluís Servià, principal investigator of the present project. The responsible of the computer centre is Joan Escobar-Ortiz. The data will be stored in a server of the center and will be coded to comply with the confidentiality of the same and for a correct anonymization of patients based on Regulatory Laws.
The study has the approval of each ethics committee of each participating centre.
Statistical analyses will be performed by the department of statistics of University of Lleida under close supervision of Javier Trujillano-Cabello and the principal investigators of the present study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with Nutritional Support
Patients expected to be admitted \>72h at the Intensive Care Unit with the need of artificial Nutritional Support
Patients with Nutritional Support
Evaluation of Enteral Nutrition or Parenteral Nutrition or both administered to the patients needing artificial Nutritional Support
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Patients with Nutritional Support
Evaluation of Enteral Nutrition or Parenteral Nutrition or both administered to the patients needing artificial Nutritional Support
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Need of ICU admission \>72h.
* Need of Artificial Nutrional Support (Enteral Nutrition or Parenteral Nutrition or both).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Arnau de Vilanova
OTHER
Hospital Universitario 12 de Octubre
OTHER
Hospital Universitari de Bellvitge
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Juan Carlos Lopez-Delgado, PhD
Intensive Care Specialist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Teodoro Grau-Carmona, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital 12 de Octubre
Lluís Servia-Goixart, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Arnau de Vilanova / Biomedical Research Institute of Lleida (IRBLleida) Institut de Recerca Biomèdica de Lleida
Juan Carlos Lopez-Delgado, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Sant Joan d' Alacant
Sant Joan d'Alacant, Alicante, Spain
H. Manacor
Manacor, Balearic Islands, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
H. General de Granollers
Granollers, Barcelona, Spain
Hospital Universitari de Bellvitge (Cardiology Unit)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Mataró
Mataró, Barcelona, Spain
Hospital Mutua Terrasa.
Terrassa, Barcelona, Spain
Hospital General Universitario de Castellón
Castellon, Castellón, Spain
Hospital Universitario de Puerto Real
Puerto Real, Cádiz, Spain
Hospital de Barbastro
Barbastro, Huesca, Spain
Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Quirón Sur
Alcorcón, Madrid, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital Infanta Cristina
Parla, Madrid, Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Universitario de A Coruña
A Coruña, , Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Plató
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau.
Barcelona, , Spain
Hospital Universitario de Burgos
Burgos, , Spain
Hospital Universitari Josep Trueta
Girona, , Spain
Hospital General San Jorge
Huesca, , Spain
Hospital Universitari Arnau de Vilanova
Lleida, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario 12 de Octubre (Trauma Unit)
Madrid, , Spain
Hospital Regional Universitario Carlos Haya
Málaga, , Spain
Hospital General Universitario Reina Sofia
Murcia, , Spain
Hosptial General Universitario Morales Meseguer
Murcia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitari Doctor Peset
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Hospital Rio Hortega
Valladolid, , Spain
Hospital Virgen de la Concha
Zamora, , Spain
Hospital Clínico Lozano Blesa
Zaragoza, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Hospital Royo Villanova
Zaragoza, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Heyland 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.
Correia 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.
Dvir 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.
Deitch 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.
Harvey 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.
Patel 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.
Artinian 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.
Flordelis 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.
Arabi 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.
National 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.
Wischmeyer 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.
Wei 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.
Lopez-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.
Servia-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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PR401/17
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.