Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
583

Summary

Conditions
  • Critical Illness
  • Intensive Care Unit
  • Nutritional Support
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT03634943
Collaborators
  • Hospital Arnau de Vilanova
  • Hospital Universitario 12 de Octubre
Investigators
Principal Investigator: Teodoro Grau-Carmona, Ph.D. Hospital 12 de Octubre Principal Investigator: Lluís Servia-Goixart, Ph.D. Hospital Arnau de Vilanova / Biomedical Research Institute of Lleida (IRBLleida) Institut de Recerca Biomèdica de Lleida Principal Investigator: Juan Carlos Lopez-Delgado, Ph.D Hospital Universitari de Bellvitge