Enteral Nutrition and Vasoactive Drugs (NUTRIVAD)

Enteral Nutrition in Critically Ill Patients Undergoing Vasoactive Drugs Therapy. The NUTRIVAD Study.

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.

Study Overview

• Status: Completed
• Conditions: Enteral Nutrition; Critical Care; Vasopressor Agents; Hemodynamics Instability
• Intervention / Treatment: Other: Enteral nutrition

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos
  • Murcia, Spain, 30003
    • Hospital General Universitario Reina Sofia
  • Andalucía
    • Málaga, Andalucía, Spain, 29010
      • Hospital Regional Universitario de Malaga
  • Aragón
    • Huesca, Aragón, Spain, 22004
      • Hospital de San Jorge
    • Huesca, Aragón, Spain, 22300
      • Hospital de Barbastro
    • Zaragoza, Aragón, Spain, 50009
      • Hospital Universitario Miguel Servet
  • Castilla Y León
    • Valladolid, Castilla Y León, Spain, 47012
      • Hospital Universitario Rio Hortega
  • Cataluña
    • Barcelona, Cataluña, Spain, 08907
      • Hospital Universitario de Bellvitge
    • Barcelona, Cataluña, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol
    • Gerona, Cataluña, Spain, 17007
      • Hospital Universitario de Girona Josep Trueta
    • Lérida, Cataluña, Spain, 25198
      • Hospital Universitario Arnau de Villanova
    • Terrassa, Cataluña, Spain, 08221
      • Hospital Universitario Mútua Terrassa
  • Comunidad Valenciana
    • Castelló de la Plana, Comunidad Valenciana, Spain, 12004
      • Hospital General Universitario de Castellon
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Hospital Clínico Universitario de Valencia
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña
    • Lugo, Galicia, Spain, 27003
      • Hospital Universitario Lucus Augusti
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07500
      • Hospital de Manacor.
  • Madrid
    • Aranjuez, Madrid, Spain, 28300
      • Hospital Universitario del Tajo
    • Fuenlabrada, Madrid, Spain, 28942
      • Hospital Universitario de Fuenlabrada
    • Leganés., Madrid, Spain, 28911
      • Hospital Universitario Severo Ochoa
    • Parla, Madrid, Spain, 28981
      • Hospital Universitario Infanta Cristina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill adults.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood lactate.	Daily peak blood lactate, in mmol/l.	Daily to a maximum of 14 days after Intensive Care Unit Admission.
Cardiac index.	Daily lowest cardiac index, in L/min/m^2	Daily to a maximum of 14 days after Intensive Care Unit Admission.
Mechanical circulatory support.	Dependence on Mechanical circulatory support (intra-aortic balloon pump, mechanical circulatory assistance, or extracorporeal membrane oxygenation).	Daily to a maximum of 14 days after Intensive Care Unit Admission.
Time from Intensive Care Unit admission to the start of enteral nutrition.	Time frame in hours from Intensive Care Unit admission to the start of enteral nutrition.	Up to 120 hours after Intensive Care Unit Admission.
Nutrition Tolerance.	Kilocalories delivered by enteral nutrition, divided by nutrition target in Kilocalories, expressed as percentage.	Daily to a maximum of 14 days after Intensive Care Unit Admission.
High gastric residual volume.	Gastric residual volume was described as high when >500 mL was obtained in each assessment.	Daily to a maximum of 14 days after Intensive Care Unit Admission
Abdominal distention.	A change in the abdomen detected in a physical examination, with an increase in abdominal cavity size relative to that recorded in the pre-enteral nutrition examination	Daily to a maximum of 14 days after Intensive Care Unit Admission.
Regurgitation.	Presence of Enteral nutrition feed in the oral cavity or oropharynx, as well as its spontaneous drainage by the oral and/or nasal route	Daily to a maximum of 14 days after Intensive Care Unit Admission.
Enteral nutrition-related diarrhea.	5 or more liquid stools in 24 hours or more than two 1000-mL stool volumes, each deposited over a 24-hour period.	Daily to a maximum of 14 days after Intensive Care Unit Admission.
Constipation.	Lack of bowel movements in 7 days from the onset of enteral nutrition or for 3 days in the first week of admission.	Daily to a maximum of 14 days after Intensive Care Unit Admission.
Bronchoaspiration.	The presence of respiratory secretions of similar characteristics to the prescribed enteral nutrition feed, confirmed by the glucose-oxidase technique in tracheal secretion.	Daily to a maximum of 14 days after Intensive Care Unit Admission.
Nasogastric tube complications.	Obstruction or misplacement/accidental extubation.	Daily to a maximum of 14 days after Intensive Care Unit Admission.
Enteral nutrition interruptions.	Need to interrupt or discontinue enteral nutrition (and reasons)	Daily to a maximum of 14 days after Intensive Care Unit Admission.

Collaborators and Investigators

• Sponsor: Hospital Severo Ochoa
• Collaborators: Hospital Universitario 12 de Octubre
• Investigators: Study Director: Jose Luis Flordelís Lasierra, MD, PhD, Hospital Universitario Severo Ochoa. Leganés. Madrid. Spain.; Study Chair: Juan Carlos Montejo González, MD, PhD, Hospital Universitario 12 de Octubre. Madrid. Spain; Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Critical Care; Enteral nutrition; Vasoactive Drugs
• Other Study ID Numbers: HSeveroOchoa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The study protocol and Informed Consent Form would be shared with other researchers
• IPD Sharing Time Frame: From January 2018 to December 2018.
• IPD Sharing Access Criteria: Contact with Dr. Flordelís Lasierra (email: makalyconru@hotmail.com).
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No