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Enteral Nutrition and Vasoactive Drugs (NUTRIVAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03401632
Recruitment Status : Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
Hospital Universitario 12 de Octubre
Information provided by (Responsible Party):
Jose Luis Flordelis Lasierra, MD, PhD, Hospital Severo Ochoa

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.

Condition or disease Intervention/treatment
Enteral Nutrition Vasopressor Agents Hemodynamics Instability Critical Care 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Enteral Nutrition in Critically Ill Patients Undergoing Vasoactive Drugs Therapy. The NUTRIVAD Study.
Actual Study Start Date : January 15, 2017
Actual Primary Completion Date : June 15, 2019
Estimated Study Completion Date : June 30, 2020

Intervention Details:
  • Other: Enteral nutrition
    Enteral nutrition support


Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Blood lactate. [ Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission. ]
    Daily peak blood lactate, in mmol/l.

  2. 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

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. Nasogastric tube complications. [ Time Frame: Daily to a maximum of 14 days after Intensive Care Unit Admission. ]
    Obstruction or misplacement/accidental extubation.

  13. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill adults.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401632


Locations
Show Show 23 study locations
Sponsors and Collaborators
Hospital Severo Ochoa
Hospital Universitario 12 de Octubre
Investigators
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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: Miguel Ángel García Martínez, MD Hospital Universitario de Torrevieja. Comunidad Valenciana. 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: Pilar Martínez García, MD Hospital Universitario Puerto Real. Cádiz. Andalucía. Spain.

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Responsible Party: Jose Luis Flordelis Lasierra, MD, PhD, Principal Investigator, Hospital Severo Ochoa
ClinicalTrials.gov Identifier: NCT03401632    
Other Study ID Numbers: HSeveroOchoa
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study protocol and Informed Consent Form would be shared with other researchers
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: From January 2018 to December 2018.
Access Criteria: Contact with Dr. Flordelís Lasierra (email: makalyconru@hotmail.com).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Luis Flordelis Lasierra, MD, PhD, Hospital Severo Ochoa:
Enteral nutrition
Vasoactive Drugs
Critical Care