Evaluation of Nutritional Practices in the Critical Care

Critical Illness Clinical Trial

— ENPIC  

Official title:

Evaluation of Nutritional Practices in the Critical Care Patient at the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634943
• Other study ID #: PR401/17
• Status: Completed
• Start date: April 23, 2018
• Est. completion date: March 22, 2022

Study information

• Verified date: March 2022
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: March 22, 2022
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care Unit
• Nutritional Support

Intervention

Other:
• Patients with Nutritional Support
Evaluation of Enteral Nutrition or Parenteral Nutrition or both administered to the patients needing artificial Nutritional Support

Locations

Country	Name	City	State
Spain	Hospital Universitario de A Coruña	A Coruña
Spain	Hospital Príncipe de Asturias	Alcalá de Henares	Madrid
Spain	Hospital Quirón Sur	Alcorcón	Madrid
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de Barbastro	Barbastro	Huesca
Spain	Hospital de la Santa Creu i Sant Pau.	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Plató	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital General Universitario de Castellón	Castelló de la Plana	Castellón
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitario de Getafe	Getafe	Madrid
Spain	Hospital Universitari Josep Trueta	Girona
Spain	H. General de Granollers	Granollers	Barcelona
Spain	Hospital General San Jorge	Huesca
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitari de Bellvitge (Cardiology Unit)	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario Severo Ochoa	Leganés	Madrid
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	H. Manacor	Manacor	Islas Baleares
Spain	Hospital de Mataró	Mataró	Barcelona
Spain	Hospital General Universitario Reina Sofia	Murcia
Spain	Hosptial General Universitario Morales Meseguer	Murcia
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Infanta Cristina	Parla	Madrid
Spain	Hospital Universitario de Puerto Real	Puerto Real	Cádiz
Spain	Hospital Sant Joan d' Alacant	San Juan De Alicante	Alicante
Spain	Hospital Universitario Infanta Sofía	San Sebastian de los Reyes	Madrid
Spain	Hospital Mutua Terrasa.	Terrassa	Barcelona
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 Álvaro Cunqueiro	Vigo	Pontevedra
Spain	Hospital Virgen de la Concha	Zamora
Spain	Hospital Clínico Lozano Blesa	Zaragoza
Spain	Hospital Miguel Servet	Zaragoza
Spain	Hospital Royo Villanova	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Hospital Arnau de Vilanova, Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

References & Publications (13)

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;3 — View 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. — View Citation

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. — View Citation

Deitch EA. Role of the gut lymphatic system in multiple organ failure. Curr Opin Crit Care. 2001 Apr;7(2):92-8. Review. — View Citation

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. — View Citation

Flordelís Lasierra JL, Pérez-Vela JL, Montejo González 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. Review. English, Spanish. — View Citation

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. — View Citation

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. — View Citation

Marik PE, Zaloga GP. Early enteral nutrition in acutely ill patients: a systematic review. Crit Care Med. 2001 Dec;29(12):2264-70. Review. Erratum in: Crit Care Med 2002 Mar;30(3):725. — View 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 wit — View 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. Review. — View 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 — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Time from Intensive Care Unit admission to the start of enteral nutrition	Time frame in hours from Intensive Care Unit admission to the start of enteral nutrition	Up to 120 hours after Intensive Care Unit Admission
Secondary	Dose of vasoactive drugs	Dose of vasoactive drugs (highest daily), in µg/kg/min	Daily to a maximum of 14 days after Intensive Care Unit Admission
Secondary	Glycaemic control	Daily measurement of maximum and minimum glucose	Daily to a maximum of 14 days after Intensive Care Unit Admission