Enteral Nutrition and Vasoactive Drugs

NCT ID: NCT03401632

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-15

Study Completion Date

2020-06-30

Brief Summary

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Enteral nutrition in critically ill patients undergoing vasoactive support due to hemodynamic instability is controversial. Hypothesis: enteral nutrition delivered in such patients can be feasible and safe.

Detailed Description

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Nutrition support in critically ill patients undergoing vasoactive support due to hemodynamic instability is controversial and challenging. However, if it is delivered according to an enteral nutrition protocol and under proper medical supervision, it can be feasible and safe. The present multicenter prospective study was designed to examine the feasibility and safety of enteral nutrition support in such patients.

Conditions

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Enteral Nutrition Vasopressor Agents Hemodynamics Instability Critical Care

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Enteral nutrition

Enteral nutrition support

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Authorization to participate in the study by informed consent.
* Dependence of vasoactive drugs and/or mechanical circulatory support to at least 48 hours from Intensive Care Unit admission.
* Invasive mechanical ventilation time of at least 48 hours.
* Expected survival greater than 72 hours.
* ICU Stay greater than or equal to 72 hours.

Exclusion Criteria

* Refusal to participate in the study.
* Refractory shock, defined as the progressive elevation of the dose of vasoactive drugs and / or markers of tissue hypoperfusion, or mean arterial pressure ≤ 60 mm Hg despite the therapeutic maneuvers.
* History of significant abdominal vascular disease (ischemic colitis, chronic mesenteric ischemia, aortic aneurysm abdominal, aortic dissection with involvement of mesenteric vessels, etc).
* Absolute contraindication for the onset of enteral nutrition (active gastrointestinal hemorrhage, intestinal obstruction, etc.) or patients with a non-functional gastrointestinal tract.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario 12 de Octubre

OTHER

Sponsor Role collaborator

Hospital Severo Ochoa

OTHER

Sponsor Role lead

Responsible Party

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Jose Luis Flordelis Lasierra, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose Luis Flordelís Lasierra, MD, PhD

Role: STUDY_DIRECTOR

Hospital Universitario Severo Ochoa. Leganés. Madrid. Spain.

Juan Carlos Montejo González, MD, PhD

Role: STUDY_CHAIR

Hospital Universitario 12 de Octubre. Madrid. Spain

Luis Juan Terceros Almanza, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre. Madrid. Spain

Antonio Luis Blesa Malpica, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Clínico San Carlos. Madrid. Spain

Emilio Renes Carreño, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre. Madrid. Spain

María Lourdes Cordero Lorenzana, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario Universitario A Coruña. Galicia. Spain.

Juan Carlos López Delgado, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Bellvitge. Cataluña. Spain.

Paola Zárate Chug, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Miguel Servet. Zaragoza. Spain.

Belén Vila García, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Infanta Cristina. Parla. Madrid. Spain

Rosa María Gastaldo Simeón, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Manacor. Mallorca. Islas Baleares. Spain

Fátima Martínez Lozano Aranaga, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Reina Sofía. Murcia. Spain.

Carolina Lorencio Cárdenas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Girona Josep Trueta. Gerona. Spain

Mónica Zamora Elson, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Barbastro. Huesca. Aragón. Spain.

Clara Vaquerizo Alonso, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Fuenlabrada. Madrid. Spain.

María Luisa Bordejé Laguna, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Germans Trias i Pujol. Badalona. Barcelona. Cataluña. Spain.

Esther Portugal Rodríguez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Lucus Augusti. Lugo. Galicia. Spain.

Lluís Servià Goixart, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Arnau de Villanova. Lérida. Cataluña. Spain.

Ana Martín Luengo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Río Ortega. Valladolid. Castilla y León. Spain

Carmen Martín Parra, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario del Tajo. Aranjuez. Madrid. Spain

Lidón Mateu Campos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario de Castellón. Comunidad Valenciana. Spain

Juan Francisco Fernández Ortega, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Regional Universitario de Málaga. Andalucía. Spain

Carlos Serón Arbeloa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de San Jorge. Huesca. Aragón. Spain

Elisabeth Navas Moya, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Mútua Terrassa. Barcelona. Spain.

María del Mar Juan Díaz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario de Valencia. Comunidad Valenciana. Spain

Alexander Agrifolio Rotaeche, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Locations

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Hospital Regional Universitario de Málaga

Málaga, Andalusia, Spain

Site Status

Hospital de San Jorge

Huesca, Aragon, Spain

Site Status

Hospital de Barbastro

Huesca, Aragon, Spain

Site Status

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain

Site Status

Hospital de Manacor.

Palma de Mallorca, Balearic Islands, Spain

Site Status

Hospital Universitario Río Hortega

Valladolid, Castille and León, Spain

Site Status

Hospital Universitario de Bellvitge

Barcelona, Catalonia, Spain

Site Status

Hospital Universitario Germans Trias i Pujol

Barcelona, Catalonia, Spain

Site Status

Hospital Universitario de Girona Josep Trueta

Girona, Catalonia, Spain

Site Status

Hospital Universitario Arnau de Villanova

Lleida, Catalonia, Spain

Site Status

Hospital Universitario Mútua Terrassa

Terrassa, Catalonia, Spain

Site Status

Complejo Hospitalario Universitario A Coruña

A Coruña, Galicia, Spain

Site Status

Hospital Universitario Lucus Augusti

Lugo, Galicia, Spain

Site Status

Hospital Universitario del Tajo

Aranjuez, Madrid, Spain

Site Status

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Site Status

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Site Status

Hospital Universitario Infanta Cristina

Parla, Madrid, Spain

Site Status

Hospital General Universitario de Castellón

Castellon, Valencia, Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Site Status

Hospital Universitario Clínico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital General Universitario Reina Sofía

Murcia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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HSeveroOchoa

Identifier Type: -

Identifier Source: org_study_id

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