Clinical trial NCT03401632: Enteral Nutrition and Vasoactive Drugs
Official title: Enteral Nutrition in Critically Ill Patients Undergoing Vasoactive Drugs Therapy. The NUTRIVAD Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enteral Nutrition
Vasopressor Agents
Hemodynamics Instability
Critical Care
Keywords: Enteral nutrition
Vasoactive Drugs
Critical Care
Lead sponsor: Hospital Severo Ochoa
Sponsor class: OTHER
Collaborators: name: Hospital Universitario 12 de Octubre
First posted: 2018-01-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill adults.

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dose of vasoactive drugs.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
measure: Kilocalories delivered by enteral route and Energy balance (Kilocalories delivered by enteral nutrition - (minus) enteral nutrition target in Kilocalories).
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
measure: Enteral nutrition-related mesenteric ischemia.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Secondary outcomes:
measure: Blood lactate.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
measure: Cardiac index.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
measure: Mechanical circulatory support.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
measure: Time from Intensive Care Unit admission to the start of enteral nutrition.
timeFrame: Up to 120 hours after Intensive Care Unit Admission.
measure: Nutrition Tolerance.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
measure: High gastric residual volume.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission
measure: Abdominal distention.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
measure: Regurgitation.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
measure: Enteral nutrition-related diarrhea.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
measure: Constipation.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
measure: Bronchoaspiration.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
measure: Nasogastric tube complications.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
measure: Enteral nutrition interruptions.
timeFrame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
state: Andalucía
city: Huesca
country: Spain
facility: Hospital de San Jorge
state: Aragón
city: Huesca
country: Spain
facility: Hospital de Barbastro
state: Aragón
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
state: Aragón
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
state: Castilla Y León
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Cataluña
city: Gerona
country: Spain
facility: Hospital Universitario de Girona Josep Trueta
state: Cataluña
city: Lérida
country: Spain
facility: Hospital Universitario Arnau de Villanova
state: Cataluña
city: Terrassa
country: Spain
facility: Hospital Universitario Mútua Terrassa
state: Cataluña
city: Castelló de la Plana
country: Spain
facility: Hospital General Universitario de Castellón
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
state: Comunidad Valenciana
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
state: Galicia
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
state: Galicia
city: Palma De Mallorca
country: Spain
facility: Hospital de Manacor.
state: Islas Baleares
city: Aranjuez
country: Spain
facility: Hospital Universitario del Tajo
state: Madrid
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Leganés.
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Parla
country: Spain
facility: Hospital Universitario Infanta Cristina
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Murcia
country: Spain
facility: Hospital General Universitario Reina Sofía
Study officials:
affiliation: Hospital Universitario Severo Ochoa. Leganés. Madrid. Spain.
name: Jose Luis Flordelís Lasierra, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario 12 de Octubre. Madrid. Spain
name: Juan Carlos Montejo González, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario 12 de Octubre. Madrid. Spain
name: Luis Juan Terceros Almanza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Clínico San Carlos. Madrid. Spain
name: Antonio Luis Blesa Malpica, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario 12 de Octubre. Madrid. Spain
name: Emilio Renes Carreño, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario Universitario A Coruña. Galicia. Spain.
name: María Lourdes Cordero Lorenzana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Bellvitge. Cataluña. Spain.
name: Juan Carlos López Delgado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Miguel Servet. Zaragoza. Spain.
name: Paola Zárate Chug, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Infanta Cristina. Parla. Madrid. Spain
name: Belén Vila García, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Manacor. Mallorca. Islas Baleares. Spain
name: Rosa María Gastaldo Simeón, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario Reina Sofía. Murcia. Spain.
name: Fátima Martínez Lozano Aranaga, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Girona Josep Trueta. Gerona. Spain
name: Carolina Lorencio Cárdenas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Barbastro. Huesca. Aragón. Spain.
name: Mónica Zamora Elson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Fuenlabrada. Madrid. Spain.
name: Clara Vaquerizo Alonso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Germans Trias i Pujol. Badalona. Barcelona. Cataluña. Spain.
name: María Luisa Bordejé Laguna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Lucus Augusti. Lugo. Galicia. Spain.
name: Esther Portugal Rodríguez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Arnau de Villanova. Lérida. Cataluña. Spain.
name: Lluís Servià Goixart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Río Ortega. Valladolid. Castilla y León. Spain
name: Ana Martín Luengo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario del Tajo. Aranjuez. Madrid. Spain
name: Carmen Martín Parra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario de Castellón. Comunidad Valenciana. Spain
name: Lidón Mateu Campos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Regional Universitario de Málaga. Andalucía. Spain
name: Juan Francisco Fernández Ortega, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de San Jorge. Huesca. Aragón. Spain
name: Carlos Serón Arbeloa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Mútua Terrassa. Barcelona. Spain.
name: Elisabeth Navas Moya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario de Valencia. Comunidad Valenciana. Spain
name: María del Mar Juan Díaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Paz
name: Alexander Agrifolio Rotaeche, MD
role: PRINCIPAL_INVESTIGATOR
References: