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Evaluation of Nutritional Practices in the Critical Care

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03634943
Acronym
ENPIC
Enrollment
642
Registered
2018-08-17
Start date
2018-04-23
Completion date
2022-03-22
Last updated
2022-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Intensive Care Unit, Nutritional Support

Keywords

Clinical Practice Guidelines

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.

Interventions

OTHERPatients with Nutritional Support

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

Sponsors

Hospital Arnau de Vilanova
CollaboratorOTHER
Hospital Universitario 12 de Octubre
CollaboratorOTHER
Hospital Universitari de Bellvitge
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Kilocalories delivered by enteral and/or parenteral route and Energy balanceDaily to a maximum of 14 days after Intensive Care Unit AdmissionKilocalories delivered by nutritional support - (minus) nutritional support target in Kilocalories
gram of proteins delivered by enteral and/or parenteral routeDaily to a maximum of 14 days after Intensive Care Unit AdmissionProteins delivered by nutritional support - (minus) nutritional support target in gram of proteins
Rate of complications related with nutritional support (Enteral and/or Parenteral route)Daily to a maximum of 14 days after Intensive Care Unit AdmissionMain 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
Rate of 28-day mortality associated with the characteristics of nutritional support (e.g., gram of proteins, etc.)Daily to a maximum of 28 days after Intensive Care Unit AdmissionInfluence of nutritional support or any nutrition-related variable on mortality during ICU admission

Secondary

MeasureTime frameDescription
Dose of vasoactive drugsDaily to a maximum of 14 days after Intensive Care Unit AdmissionDose of vasoactive drugs (highest daily), in μg/kg/min
Glycaemic controlDaily to a maximum of 14 days after Intensive Care Unit AdmissionDaily measurement of maximum and minimum glucose
Time from Intensive Care Unit admission to the start of enteral nutritionUp to 120 hours after Intensive Care Unit AdmissionTime frame in hours from Intensive Care Unit admission to the start of enteral nutrition

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026