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| Name | Class |
|---|---|
| University of Castilla-La Mancha | OTHER |
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The goal of this clinical trial is to Determine efficacy of intermittent enteral nutrition vs continuous enteral nutrition in adults patients with a nasogastric tube in a intensive care unit.
The main question[s] it aims to answer are:
The participants will be randomized into two groups: control group (continuous enteral nutrition) or experimental group (intermittent enteral nutrition) Researchers will compare intermittent enteral nutrition vs continuous to see if there is a reduction in gastrointestinal and respiratory complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INTERMITTENT ENTERAL NUTRITITION (IEN) | Experimental | Administration of Enteral Nutriton (EN) by nasogastric tube in 4 bolus (24h): Duration of the infusion 1hour each shot, using an infusion pump. |
|
| CONTINUOUS ENTERAL NUTRITION (CEN) | Active Comparator | Administration of Enteral Nutriton (EN) by nasogastric tube during 24 hours, using an infusion pump. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INTERMITTENT ENTERAL NUTRITITION (IEN) | Other | Administration of Enteral Nutriton (EN) by nasogastric tube in 4 bolus (24h): Duration of the infusion 1hour each shot, using an infusion pump. |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Complications | Respiratory aspiration of gastric content | during ICU stay (maximum 15 days) |
| Gastrointestinal Complications | Digestive intolerance: Diarrhea, vomiting, increased gastric residual volume(GRV) | during ICU stay (maximum 15 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of the caloric objective | Time in hours to reach caloric goal | during ICU stay (up to 15 days) |
| Nutritional status: MNA | Measure with:Mini Nutritional Assessment,(MNA) 12-14 points: Normal nutritional status 8-11 points: risk of malnutrition 0-7 points: Malnutrition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| M.Dolores Saiz-Vinuesa, NURSE | Contact | 0034967597100 | 21686 | tebisama@hotmail.com |
| M.Pilar Córcoles-Jimenez, NURSE | Contact | 0034967597169 | 37169 | pcorcoles@sescam.org |
| Name | Affiliation | Role |
|---|---|---|
| M.Dolores Saiz-Vinuesa, NURSE | Gerencia de Atención Integrada de Albacete | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Dolores Saiz Vinuesa | Recruiting | Albacete | 02008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19372071 | Background | Chen YC. Critical analysis of the factors associated with enteral feeding in preventing VAP: a systematic review. J Chin Med Assoc. 2009 Apr;72(4):171-8. doi: 10.1016/S1726-4901(09)70049-8. | |
| 29883514 | Result | Lewis SR, Schofield-Robinson OJ, Alderson P, Smith AF. Enteral versus parenteral nutrition and enteral versus a combination of enteral and parenteral nutrition for adults in the intensive care unit. Cochrane Database Syst Rev. 2018 Jun 8;6(6):CD012276. doi: 10.1002/14651858.CD012276.pub2. |
| Label | URL |
|---|---|
| Effectiveness of continuous enteral nutrition versus intermittent enteral nutrition in intensive care patients: a systematic review. | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 4, 2026 | |
| Reset | Mar 24, 2026 |
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The patients wil be allocated to expriemental group or control group using a simple randomization sequence.
There is an allocation concealment using sealed opaque envelopes Duration: From February 2022 to complete sample number.
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By the nature of the intervention(intermittent or continuous administration of enteral nutrition) is impossible to mask it to participats, care provider or investigators.
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| CONTINUOS ENTERAL NUTRITITION (CEN) | Other | Administration of Enteral Nutriton (EN) by nasogastric tube during 24 hours, using an infusion pump. |
|
| up to two days after admission to the ICU |
| Changes in blood glucose | Episodes of hypoglycemia or hyperglycemia | during ICU stay (maximum 15 days) |
| ICU Stay | Days of stay in ICU | From date of randomization until 100 months |
| Mortality | Percentage of deaths in ICU | until the date of death from any cause until 100 months |
| Change of type of EN administration | Change of EN administration modality | during ICU stay (maximum 15 days) |
| Nutritional status:Glim Criteria | Measure with: Glim criteria: Phenotypic criteria:Non-volitional weight loss (%) Low BMI (kg/m2)Reduced muscle mass(calf circumference (cm)) Etiologic criteria: Reduced food intake or assimilation. Inflammation *Requires at least one phenotypic criterion and one etiologic criterion for the diagnosis of malnutrition | up to two days after admission to the ICU |
| Nutritional status: Biochemical values | Measure with:biochemical values: albumin, prealbumin, total protein | up to two days after admission to the ICU |
| 30348463 | Result | Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29. |
| 29232262 | Result | Patel JJ, Rosenthal MD, Heyland DK. Intermittent versus continuous feeding in critically ill adults. Curr Opin Clin Nutr Metab Care. 2018 Mar;21(2):116-120. doi: 10.1097/MCO.0000000000000447. |
| 24559000 | Result | Tavares de Araujo VM, Gomes PC, Caporossi C. Enteral nutrition in critical patients; should the administration be continuous or intermittent? Nutr Hosp. 2014 Mar 1;29(3):563-7. doi: 10.3305/nh.2014.29.3.7169. |
| 12754584 | Result | Serpa LF, Kimura M, Faintuch J, Ceconello I. Effects of continuous versus bolus infusion of enteral nutrition in critical patients. Rev Hosp Clin Fac Med Sao Paulo. 2003 Jan-Feb;58(1):9-14. doi: 10.1590/s0041-87812003000100003. Epub 2003 Apr 30. |
| 29924423 | Result | Ichimaru S. Methods of Enteral Nutrition Administration in Critically Ill Patients: Continuous, Cyclic, Intermittent, and Bolus Feeding. Nutr Clin Pract. 2018 Dec;33(6):790-795. doi: 10.1002/ncp.10105. Epub 2018 Jun 20. |
| 34965317 | Result | Thong D, Halim Z, Chia J, Chua F, Wong A. Systematic review and meta-analysis of the effectiveness of continuous vs intermittent enteral nutrition in critically ill adults. JPEN J Parenter Enteral Nutr. 2022 Aug;46(6):1243-1257. doi: 10.1002/jpen.2324. Epub 2022 Feb 13. |
| 36284334 | Result | Heffernan AJ, Talekar C, Henain M, Purcell L, Palmer M, White H. Comparison of continuous versus intermittent enteral feeding in critically ill patients: a systematic review and meta-analysis. Crit Care. 2022 Oct 25;26(1):325. doi: 10.1186/s13054-022-04140-8. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 4, 2026 | Mar 24, 2026 |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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