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NCT05879263 Clinical Trial

"Efficacy of Intermittent Enteral Nutrition Versus Continuous Administration in Intensive Care"

Critical Care Clinical Trial

— ENINCO  

Official title:
"Efficacy of Intermittent Enteral Nutrition Versus Continuous Administration in Intensive Care Patients for the Reduction of Complications. Randomized Clinical Trial"

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05879263
Other study ID # CHUA_59_07_2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 10, 2022
Est. completion date April 30, 2024

Study information
Verified date May 2023
Source Complejo Hospitalario Universitario de Albacete
Contact M.Dolores Saiz-Vinuesa, NURSE
Phone 0034967597100
Email tebisama@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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: - Reduction of gastrointestinal and respiratory complications - Evaluate the achievement of the caloric objective Informed consent will be requested from participants who meet the inclusion criteria. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 190
Est. completion date April 30, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients admitted to ICU of University General Hospital of Albacete - Need for enteral nutrition by nasogastric tube in the first 48 hours - Signed informed consent Exclusion Criteria: - Insulin dependent diabetic patients - Abdominal surgery - Dire prognosis

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• INTERMITTENT ENTERAL NUTRITITION (IEN)
Administration of Enteral Nutriton (EN) by nasogastric tube in 4 bolus (24h): Duration of the infusion 1hour each shot, using an infusion pump.
• CONTINUOS ENTERAL NUTRITITION (CEN)
Administration of Enteral Nutriton (EN) by nasogastric tube during 24 hours, using an infusion pump.

Locations
Country Name City State
Spain Maria Dolores Saiz Vinuesa Albacete

Sponsors (2)
Lead Sponsor Collaborator
Complejo Hospitalario Universitario de Albacete University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. — View Citation

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/s13054-022-0414 — View Citation

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. — View Citation

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. do — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Ep — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Respiratory Complications Respiratory aspiration of gastric content during ICU stay (maximum 15 days)
Primary Gastrointestinal Complications Digestive intolerance: Diarrhea, vomiting, increased gastric residual volume(GRV) during ICU stay (maximum 15 days)
Secondary Achievement of the caloric objective Time in hours to reach caloric goal during ICU stay (up to 15 days)
Secondary 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 up to two days after admission to the ICU
Secondary Changes in blood glucose Episodes of hypoglycemia or hyperglycemia during ICU stay (maximum 15 days)
Secondary ICU Stay Days of stay in ICU From date of randomization until 100 months
Secondary Mortality Percentage of deaths in ICU until the date of death from any cause until 100 months
Secondary Change of type of EN administration Change of EN administration modality during ICU stay (maximum 15 days)
Secondary 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
Secondary Nutritional status: Biochemical values Measure with:biochemical values: albumin, prealbumin, total protein up to two days after admission to the ICU
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