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| Name | Class |
|---|---|
| Hospital Universitario 12 de Octubre | OTHER |
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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteral nutrition | Other | Enteral nutrition support |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill adults.
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| Name | Affiliation | Role |
|---|---|---|
| Jose Luis Flordelís Lasierra, MD, PhD | Hospital Universitario Severo Ochoa. Leganés. Madrid. Spain. | Study Director |
| Juan Carlos Montejo González, MD, PhD | Hospital Universitario 12 de Octubre. Madrid. Spain | Study Chair |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional Universitario de Málaga | Málaga | Andalusia | 29010 | Spain | ||
| Hospital de San Jorge |
The study protocol and Informed Consent Form would be shared with other researchers
From January 2018 to December 2018.
Contact with Dr. Flordelís Lasierra (email: makalyconru@hotmail.com).
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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| 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. |
| 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 | Principal Investigator |
| Huesca |
| Aragon |
| 22004 |
| Spain |
| Hospital de Barbastro | Huesca | Aragon | 22300 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | Aragon | 50009 | Spain |
| Hospital de Manacor. | Palma de Mallorca | Balearic Islands | 07500 | Spain |
| Hospital Universitario Río Hortega | Valladolid | Castille and León | 47012 | Spain |
| Hospital Universitario de Bellvitge | Barcelona | Catalonia | 08907 | Spain |
| Hospital Universitario Germans Trias i Pujol | Barcelona | Catalonia | 08916 | Spain |
| Hospital Universitario de Girona Josep Trueta | Girona | Catalonia | 17007 | Spain |
| Hospital Universitario Arnau de Villanova | Lleida | Catalonia | 25198 | Spain |
| Hospital Universitario Mútua Terrassa | Terrassa | Catalonia | 08221 | Spain |
| Complejo Hospitalario Universitario A Coruña | A Coruña | Galicia | 15006 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | Galicia | 27003 | Spain |
| Hospital Universitario del Tajo | Aranjuez | Madrid | 28300 | Spain |
| Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid | 28942 | Spain |
| Hospital Universitario Severo Ochoa | Leganés | Madrid | 28911 | Spain |
| Hospital Universitario Infanta Cristina | Parla | Madrid | 28981 | Spain |
| Hospital General Universitario de Castellón | Castellon | Valencia | 12004 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | Valencia | 46010 | Spain |
| Hospital Universitario Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital General Universitario Reina Sofía | Murcia | 30003 | Spain |