Enteral NutritionNUTRIVADNCT03401632

Enteral Nutrition and Vasoactive Drugs

An observational study of Enteral Nutrition and Vasopressor Agents, run by Hospital Severo Ochoa at 23 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Enteral Nutrition, Vasopressor Agents, Hemodynamics Instability
What is being tested?: Enteral nutrition
How many people: 200 participants
Where: 23 sitesSpain
Study dates: 15 Jan 2017to 30 Jun 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Critically ill adults.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

Spain23 sites

Complejo Hospitalario Universitario A Coruña
A Coruña, Galicia, 15006
Hospital Universitario del Tajo
Aranjuez, Madrid, 28300
Hospital Universitario de Bellvitge
Barcelona, Catalonia, 08907
Hospital Universitario Germans Trias i Pujol
Barcelona, Catalonia, 08916
Hospital General Universitario de Castellón
Castellon, Valencia, 12004
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital Universitario de Girona Josep Trueta
Girona, Catalonia, 17007
Hospital de San Jorge
Huesca, Aragon, 22004
Hospital de Barbastro
Huesca, Aragon, 22300
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911
Hospital Universitario Arnau de Villanova
Lleida, Catalonia, 25198
Hospital Universitario Lucus Augusti
Lugo, Galicia, 27003
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Regional Universitario de Málaga
Málaga, Andalusia, 29010
Hospital General Universitario Reina Sofía
Murcia, 30003
Hospital de Manacor.
Palma de Mallorca, Balearic Islands, 07500
Hospital Universitario Infanta Cristina
Parla, Madrid, 28981
Hospital Universitario Mútua Terrassa
Terrassa, Catalonia, 08221
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010
Hospital Universitario Río Hortega
Valladolid, Castille and León, 47012
Hospital Universitario Miguel Servet
Zaragoza, Aragon, 50009

Other trials in Spain

About this study

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

Read the 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.

Conditions: Enteral Nutrition, Vasopressor Agents, Hemodynamics Instability, Critical Care
Being tested: Enteral nutrition
Keywords: Enteral nutrition, Vasoactive Drugs, Critical Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enteral nutritionOther
Enteral nutrition support

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose of vasoactive drugs.
Dose of vasoactive drugs (highest daily), in μg/kg/min.
Measured: 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.
Measured: 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.
Measured: Daily to a maximum of 14 days after Intensive Care Unit Admission.

Secondary outcomes (13)

Blood lactate.
Daily peak blood lactate, in mmol/l.
Measured: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Cardiac index.
Daily lowest cardiac index, in L/min/m^2
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Nasogastric tube complications.
Obstruction or misplacement/accidental extubation.
Measured: Daily to a maximum of 14 days after Intensive Care Unit Admission.
Enteral nutrition interruptions.
Need to interrupt or discontinue enteral nutrition (and reasons)
Measured: Daily to a maximum of 14 days after Intensive Care Unit Admission.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 201730 Jun 2020

First posted17 Jan 2018
Study start15 Jan 2017
Primary completion1 Mar 2020
Study completion30 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Enteral NutritionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03401632
Sponsor's protocol ID: HSeveroOchoa
Acronym: NUTRIVAD
Status last verified: Jul 2020
First submitted: 3 Jan 2018
Last updated: 29 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The study protocol and Informed Consent Form would be shared with other researchers

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Not yet recruitingObservational study
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)

All Enteral Nutrition trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enteral Nutrition in Critically Ill Patients Undergoing Vasoactive Drugs Therapy. The NUTRIVAD Study.
ClinicalTrials.gov ID: NCT03401632
Acronym / sponsor ID: NUTRIVAD / HSeveroOchoa
Conditions: Enteral Nutrition, Vasopressor Agents, Hemodynamics Instability, Critical Care
Keywords: Enteral nutrition, Vasoactive Drugs, Critical Care
Study type: Observational
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Hospital Severo OchoaUniversity, hospital or other
Collaborators: Hospital Universitario 12 de Octubre
Study start: 15 Jan 2017 (actual)
Primary completion: 1 Mar 2020 (actual)
Study completion: 30 Jun 2020 (actual)
First posted: 17 Jan 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Critically ill adults.

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enteral nutritionEnteral nutrition support	Other	–

Primary outcome

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.
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.
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.

13 secondary outcomes

Blood lactate.
Time frame: 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.
Mechanical circulatory support.
Time frame: 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.
Nutrition Tolerance.
Time frame: 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
Abdominal distention.
Time frame: 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.
Enteral nutrition-related diarrhea.
Time frame: 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.
Bronchoaspiration.
Time frame: 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.
Enteral nutrition interruptions.
Time frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
Individual participant dataSharing planned: Yes. The study protocol and Informed Consent Form would be shared with other researchers

Related trials for Enteral Nutrition

RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Not yet recruitingObservational study
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jose Luis Flordelís Lasierra, MD, PhD study director

Hospital Universitario Severo Ochoa. Leganés. Madrid. Spain.

Juan Carlos Montejo González, MD, PhD study chair

Hospital Universitario 12 de Octubre. Madrid. Spain

Luis Juan Terceros Almanza, MD principal investigator

Hospital Universitario 12 de Octubre. Madrid. Spain

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Enteral Nutrition and Vasopressor Agents, run by Hospital Severo Ochoa at 23 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose of vasoactive drugs. (time frame: Daily to a maximum of 14 days after Intensive Care Unit Admission.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03401632.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.