Skip to main content
OpenTrials
Completed

NCT Number: NCT03401632

Enteral Nutrition and Vasoactive Drugs

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Enteral Nutrition Critical Care Hemodynamics Instability Vasopressor Agents

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Regional Universitario de Málaga, Málaga, Andalusia, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enteral nutrition

Other

Enteral nutrition support

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hospital Severo Ochoa

Other

Collaborators

  • Hospital Universitario 12 de Octubre

Registry information

Official study title

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

Acronym: NUTRIVAD

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 17, 2018
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.