Clinical trial NCT03634943: Evaluation of Nutritional Practices in the Critical Care
Official title: Evaluation of Nutritional Practices in the Critical Care Patient at the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Support
Intensive Care Unit
Critical Illness
Keywords: Clinical Practice Guidelines
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Hospital Arnau de Vilanova
name: Hospital Universitario 12 de Octubre
First posted: 2018-08-17
Enrollment: 642
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Critical Care patients needing Artificial Nutritional Support

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.

Detailed description: Methods (additional information): The NS (Nutritional Support) in the ICUs will be administered according to the usual practice of the medical and nursing staff and to the protocols established in each unit. The rate of initiation, the dose of macronutrients and the increase in contributions will be made according to the criteria of each participating ICU and the responsible physician (including the use of prokinetics or parenteral nutrition).

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.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old.
* Need of ICU admission \>72h.
* Need of Artificial Nutrional Support (Enteral Nutrition or Parenteral Nutrition or both).

Exclusion Criteria:

* Not specific exclusion criteria.

Primary outcomes:
measure: Kilocalories delivered by enteral and/or parenteral route and Energy balance
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission
measure: gram of proteins delivered by enteral and/or parenteral route
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission
measure: Rate of complications related with nutritional support (Enteral and/or Parenteral route)
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission
measure: Rate of 28-day mortality associated with the characteristics of nutritional support (e.g., gram of proteins, etc.)
timeFrame: Daily to a maximum of 28 days after Intensive Care Unit Admission
Secondary outcomes:
measure: Time from Intensive Care Unit admission to the start of enteral nutrition
timeFrame: Up to 120 hours after Intensive Care Unit Admission
measure: Dose of vasoactive drugs
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission
measure: Glycaemic control
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission
Other outcomes:
Locations:
city: San Juan De Alicante
country: Spain
facility: Hospital Sant Joan d' Alacant
state: Alicante
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Granollers
country: Spain
facility: H. General de Granollers
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge (Cardiology Unit)
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua Terrasa.
state: Barcelona
city: Castelló de la Plana
country: Spain
facility: Hospital General Universitario de Castellón
state: Castellón
city: Puerto Real
country: Spain
facility: Hospital Universitario de Puerto Real
state: Cádiz
city: Barbastro
country: Spain
facility: Hospital de Barbastro
state: Huesca
city: Manacor
country: Spain
facility: H. Manacor
state: Islas Baleares
city: Alcalá de Henares
country: Spain
facility: Hospital Príncipe de Asturias
state: Madrid
city: Alcorcón
country: Spain
facility: Hospital Quirón Sur
state: Madrid
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Parla
country: Spain
facility: Hospital Infanta Cristina
state: Madrid
city: San Sebastian de los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofía
state: Madrid
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Pontevedra
city: A Coruña
country: Spain
facility: Hospital Universitario de A Coruña
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Plató
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau.
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Girona
country: Spain
facility: Hospital Universitari Josep Trueta
city: Huesca
country: Spain
facility: Hospital General San Jorge
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre (Trauma Unit)
city: Murcia
country: Spain
facility: Hospital General Universitario Reina Sofia
city: Murcia
country: Spain
facility: Hosptial General Universitario Morales Meseguer
city: Málaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari Doctor Peset
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Valladolid
country: Spain
facility: Hospital Rio Hortega
city: Zamora
country: Spain
facility: Hospital Virgen de la Concha
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Zaragoza
country: Spain
facility: Hospital Royo Villanova
Study officials:
affiliation: Hospital 12 de Octubre
name: Teodoro Grau-Carmona, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Arnau de Vilanova / Biomedical Research Institute of Lleida (IRBLleida) Institut de Recerca Biomèdica de Lleida
name: Lluís Servia-Goixart, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari de Bellvitge
name: Juan Carlos Lopez-Delgado, Ph.D
role: PRINCIPAL_INVESTIGATOR
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.