Enteral Nutrition and Vasoactive Drugs

NCT03401632 | Completed

• 1 other identifier: HSeveroOchoa
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 23

Brief Summary

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.

Conditions

Enteral Nutrition; Vasopressor Agents; Hemodynamics Instability; Critical Care

Keywords

Enteral nutrition; Vasoactive Drugs; Critical Care

Outcome Measures

Primary Outcomes (3)

• Dose of vasoactive drugs.

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

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

• Kilocalories delivered by enteral route and Energy balance (Kilocalories delivered by enteral nutrition - (minus) enteral nutrition target in Kilocalories).

  Main Enteral nutrition efficacy-related variables. Enteral nutrition target was 25 Kilocalories/Kg, if body mass index (BMI) was between 20 and 30. Corrections were made if BMI was under 20/ or over 30.

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

• Enteral nutrition-related mesenteric ischemia.

  Main enteral nutrition- safety related variable, suspected by the presence of warning signs (clinical, analytical, radiological), confirmed by laparotomy/laparoscopy, arteriography or angio-CT.

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

Secondary Outcomes (13)

• Blood lactate.

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

• Cardiac index.

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

• Mechanical circulatory support.

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

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

  Up to 120 hours after Intensive Care Unit Admission.

• Nutrition Tolerance.

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

Interventions

Enteral nutrition OTHER

Enteral nutrition support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill adults.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Severo Ochoa: lead
• Hospital Universitario 12 de Octubre: collaborator

Study Sites (23)

Hospital Regional Universitario de Málaga

Málaga, Andalusia, 29010, Spain

Location

Hospital de San Jorge

Huesca, Aragon, 22004, Spain

Location

Hospital de Barbastro

Huesca, Aragon, 22300, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain

Location

Hospital de Manacor.

Palma de Mallorca, Balearic Islands, 07500, Spain

Location

Hospital Universitario Río Hortega

Valladolid, Castille and León, 47012, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, Catalonia, 08907, Spain

Location

Hospital Universitario Germans Trias i Pujol

Barcelona, Catalonia, 08916, Spain

Location

Hospital Universitario de Girona Josep Trueta

Girona, Catalonia, 17007, Spain

Location

Hospital Universitario Arnau de Villanova

Lleida, Catalonia, 25198, Spain

Location

Hospital Universitario Mútua Terrassa

Terrassa, Catalonia, 08221, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, Galicia, 15006, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Galicia, 27003, Spain

Location

Hospital Universitario del Tajo

Aranjuez, Madrid, 28300, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario Infanta Cristina

Parla, Madrid, 28981, Spain

Location

Hospital General Universitario de Castellón

Castellon, Valencia, 12004, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital General Universitario Reina Sofía

Murcia, 30003, Spain

Location

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Jose Luis Flordelís Lasierra, MD, PhD

  Hospital Universitario Severo Ochoa. Leganés. Madrid. Spain.

  STUDY DIRECTOR

• Juan Carlos Montejo González, MD, PhD

  Hospital Universitario 12 de Octubre. Madrid. Spain

  STUDY CHAIR

• Luis Juan Terceros Almanza, MD

  Hospital Universitario 12 de Octubre. Madrid. Spain

  PRINCIPAL INVESTIGATOR

• Antonio Luis Blesa Malpica, MD, PhD

  Hospital Universitario Clínico San Carlos. Madrid. Spain

  PRINCIPAL INVESTIGATOR

• Emilio Renes Carreño, MD, PhD

  Hospital Universitario 12 de Octubre. Madrid. Spain

  PRINCIPAL INVESTIGATOR

• María Lourdes Cordero Lorenzana, MD

  Complejo Hospitalario Universitario A Coruña. Galicia. Spain.

  PRINCIPAL INVESTIGATOR

• Juan Carlos López Delgado, MD, PhD

  Hospital Universitario de Bellvitge. Cataluña. Spain.

  PRINCIPAL INVESTIGATOR

• Paola Zárate Chug, MD

  Hospital Universitario Miguel Servet. Zaragoza. Spain.

  PRINCIPAL INVESTIGATOR

• Belén Vila García, MD

  Hospital Universitario Infanta Cristina. Parla. Madrid. Spain

  PRINCIPAL INVESTIGATOR

• Rosa María Gastaldo Simeón, MD

  Hospital de Manacor. Mallorca. Islas Baleares. Spain

  PRINCIPAL INVESTIGATOR

• Fátima Martínez Lozano Aranaga, MD

  Hospital General Universitario Reina Sofía. Murcia. Spain.

  PRINCIPAL INVESTIGATOR

• Carolina Lorencio Cárdenas, MD

  Hospital Universitario de Girona Josep Trueta. Gerona. Spain

  PRINCIPAL INVESTIGATOR

• Mónica Zamora Elson, MD

  Hospital de Barbastro. Huesca. Aragón. Spain.

  PRINCIPAL INVESTIGATOR

• Clara Vaquerizo Alonso, MD

  Hospital Universitario de Fuenlabrada. Madrid. Spain.

  PRINCIPAL INVESTIGATOR

• María Luisa Bordejé Laguna, MD

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

  PRINCIPAL INVESTIGATOR

• Esther Portugal Rodríguez, MD

  Hospital Universitario Lucus Augusti. Lugo. Galicia. Spain.

  PRINCIPAL INVESTIGATOR

• Lluís Servià Goixart, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Ana Martín Luengo, MD

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

  PRINCIPAL INVESTIGATOR

• Carmen Martín Parra, MD

  Hospital Universitario del Tajo. Aranjuez. Madrid. Spain

  PRINCIPAL INVESTIGATOR

• Lidón Mateu Campos, MD, PhD

  Hospital General Universitario de Castellón. Comunidad Valenciana. Spain

  PRINCIPAL INVESTIGATOR

• Juan Francisco Fernández Ortega, MD

  Hospital Regional Universitario de Málaga. Andalucía. Spain

  PRINCIPAL INVESTIGATOR

• Carlos Serón Arbeloa, MD, PhD

  Hospital de San Jorge. Huesca. Aragón. Spain

  PRINCIPAL INVESTIGATOR

• Elisabeth Navas Moya, MD

  Hospital Universitario Mútua Terrassa. Barcelona. Spain.

  PRINCIPAL INVESTIGATOR

• María del Mar Juan Díaz, MD

  Hospital Clínico Universitario de Valencia. Comunidad Valenciana. Spain

  PRINCIPAL INVESTIGATOR

• Alexander Agrifolio Rotaeche, MD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 17, 2018
• Study Start: January 15, 2017
• Primary Completion: March 1, 2020
• Study Completion: June 30, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: From January 2018 to December 2018.
• Access Criteria: Contact with Dr. Flordelís Lasierra (email: makalyconru@hotmail.com).

Locations

ES (23)