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Nutritional SupportENPICNCT03634943

Evaluation of Nutritional Practices in the Critical Care

An observational study of Nutritional Support and Intensive Care Unit, run by Hospital Universitari de Bellvitge at 43 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Patients with Nutritional Support
How many people
642 participants
Where
43 sitesSpain
Study dates
23 Apr 2018to 22 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult Critical Care patients needing Artificial Nutritional Support

Who may be able to join

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

Who cannot join

  • Not specific exclusion criteria.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

Spain43 sites

  • Hospital Universitario de A Coruña

    A Coruña, 15006

  • Hospital Príncipe de Asturias

    Alcalá de Henares, Madrid, 28805

  • Hospital Quirón Sur

    Alcorcón, Madrid, 28922

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital de Barbastro

    Barbastro, Huesca, 22300

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Plató

    Barcelona, 08006

  • Hospital de la Santa Creu i Sant Pau.

    Barcelona, 08041

  • Hospital Universitario de Burgos

    Burgos, 09006

  • Hospital General Universitario de Castellón

    Castellon, Castellón, 12004

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942

  • Hospital Universitario de Getafe

    Getafe, Madrid, 28905

  • Hospital Universitari Josep Trueta

    Girona, 17007

  • H. General de Granollers

    Granollers, Barcelona, 08402

  • Hospital General San Jorge

    Huesca, 22004

  • Hospital Universitari de Bellvitge (Cardiology Unit)

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid, 28911

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario 12 de Octubre (Trauma Unit)

    Madrid

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010

  • H. Manacor

    Manacor, Balearic Islands, 07500

  • Hospital de Mataró

    Mataró, Barcelona, 08304

  • Hospital General Universitario Reina Sofia

    Murcia, 30003

  • Hosptial General Universitario Morales Meseguer

    Murcia, 30008

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Infanta Cristina

    Parla, Madrid, 28981

  • Hospital Universitario de Puerto Real

    Puerto Real, Cádiz, 11510

  • Hospital Universitario Infanta Sofía

    San Sebastián de los Reyes, Madrid, 28703

  • Hospital Sant Joan d' Alacant

    Sant Joan d'Alacant, Alicante, 03550

  • Hospital Mutua Terrasa.

    Terrassa, Barcelona, 08221

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari Doctor Peset

    Valencia, 46017

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

  • Hospital Rio Hortega

    Valladolid, 47012

  • Hospital Álvaro Cunqueiro

    Vigo, Pontevedra, 36312

  • Hospital Virgen de la Concha

    Zamora, 49022

  • Hospital Clínico Lozano Blesa

    Zaragoza, 50009

  • Hospital Miguel Servet

    Zaragoza, 50009

  • Hospital Royo Villanova

    Zaragoza, 50015

Other trials in Spain

About this study

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

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.

Read more

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.

Read the 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.

Being tested
Patients with Nutritional Support
Keywords
Clinical Practice Guidelines
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients with Nutritional SupportOther

    Evaluation of Enteral Nutrition or Parenteral Nutrition or both administered to the patients needing artificial Nutritional Support

Study groups in NCT03634943
Study groupRoleWhat they receive
Patients with Nutritional SupportPatients expected to be admitted >72h at the Intensive Care Unit with the need of artificial Nutritional Support
Receives: Other: Patients with Nutritional Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kilocalories delivered by enteral and/or parenteral route and Energy balance

    Kilocalories delivered by nutritional support - (minus) nutritional support target in Kilocalories

    Measured: Daily to a maximum of 14 days after Intensive Care Unit Admission

  2. gram of proteins delivered by enteral and/or parenteral route

    Proteins delivered by nutritional support - (minus) nutritional support target in gram of proteins

    Measured: Daily to a maximum of 14 days after Intensive Care Unit Admission

  3. 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

    Measured: Daily to a maximum of 14 days after Intensive Care Unit Admission

  4. 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

    Measured: Daily to a maximum of 28 days after Intensive Care Unit Admission

Secondary outcomes (3)

  1. 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

    Measured: Up to 120 hours after Intensive Care Unit Admission

  2. Dose of vasoactive drugs

    Dose of vasoactive drugs (highest daily), in μg/kg/min

    Measured: Daily to a maximum of 14 days after Intensive Care Unit Admission

  3. Glycaemic control

    Daily measurement of maximum and minimum glucose

    Measured: Daily to a maximum of 14 days after Intensive Care Unit Admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2018
  2. Study start23 Apr 2018
  3. Primary completion15 Sep 2018
  4. Study completion22 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
642 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03634943
Sponsor's protocol ID
PR401/17
Acronym
ENPIC
Status last verified
Mar 2022
First submitted
12 Aug 2018
Last updated
23 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be analyzed by the principal investigators of each participating hospital. Share IPD is not allowed in the present study to other researchers.

Publications

  • 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.

    PubMed 11801821

  • 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.

    PubMed 7774216

  • 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.

    PubMed 12765661

  • 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.

    PubMed 16321459

  • 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.

    PubMed 11373517

  • 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.

    PubMed 25271389

  • 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.

    PubMed 27016160

  • 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.

    PubMed 16608945

  • 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.

    PubMed 24907000

  • 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.

    PubMed 25992505

  • 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.

    PubMed 22307571

  • 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.

    PubMed 27327244

  • 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.

    PubMed 25855901

  • 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.

    PubMed 37693244

  • 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.

    PubMed 35063222

Questions about this trial

What is this clinical trial studying?

An observational study of Nutritional Support and Intensive Care Unit, run by Hospital Universitari de Bellvitge at 43 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kilocalories delivered by enteral and/or parenteral route and Energy balance (time frame: Daily to a maximum of 14 days after Intensive Care Unit Admission). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03634943, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.

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