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Completed

NCT Number: NCT03634943

Evaluation of Nutritional Practices in the Critical Care

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.

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Key information

Conditions

Nutritional Support Critical Illness Disease Attributes Intensive Care Unit Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Sant Joan d' Alacant, Sant Joan d'Alacant, Alicante, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patients with Nutritional Support

Other

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

Primary outcomes

  1. 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

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

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

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

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

  3. Rate of complications related with nutritional support (Enteral and/or Parenteral route)

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

    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

  4. Rate of 28-day mortality associated with the characteristics of nutritional support (e.g., gram of proteins, etc.)

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

    Influence of nutritional support or any nutrition-related variable on mortality during ICU admission

Secondary outcomes

  1. Time from Intensive Care Unit admission to the start of enteral nutrition

    Time frame: Up to 120 hours after Intensive Care Unit Admission

    Time frame in hours from Intensive Care Unit admission to the start of enteral nutrition

  2. Dose of vasoactive drugs

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

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

  3. Glycaemic control

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

    Daily measurement of maximum and minimum glucose

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Collaborators

  • Hospital Arnau de Vilanova
  • Hospital Universitario 12 de Octubre

Registry information

Official study title

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

Acronym: ENPIC

Important dates

Study start
2018
Primary completion
2018
Study completion
2022
First posted
Aug 17, 2018
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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