Enteral Nutrition and Vasoactive Drugs (NUTRIVAD)

July 27, 2020 updated by: Jose Luis Flordelis Lasierra, MD, PhD, Hospital Severo Ochoa

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose of vasoactive drugs.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
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).
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
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.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood lactate.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Daily peak blood lactate, in mmol/l.
Daily to a maximum of 14 days after Intensive Care Unit Admission.
Cardiac index.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Daily lowest cardiac index, in L/min/m^2
Daily to a maximum of 14 days after Intensive Care Unit Admission.
Mechanical circulatory support.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
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: Up to 120 hours after Intensive Care Unit Admission.
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.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
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.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission
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.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
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.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
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.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
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.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
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.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
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.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Obstruction or misplacement/accidental extubation.
Daily to a maximum of 14 days after Intensive Care Unit Admission.
Enteral nutrition interruptions.
Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Need to interrupt or discontinue enteral nutrition (and reasons)
Daily to a maximum of 14 days after Intensive Care Unit Admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Severo Ochoa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Universitario 12 de Octubre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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