"Efficacy of Intermittent Enteral Nutrition Versus Continuous Administration in Intensive Care"
ENINCO
1 other identifier
interventional
190
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2022
CompletedFirst Submitted
Initial submission to the registry
May 3, 2023
CompletedFirst Posted
Study publicly available on registry
May 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedMay 30, 2023
May 1, 2023
2.1 years
May 3, 2023
May 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Secondary Outcomes (8)
Achievement of the caloric objective
during ICU stay (up to 15 days)
Nutritional status: MNA
up to two days after admission to the ICU
Changes in blood glucose
during ICU stay (maximum 15 days)
ICU Stay
From date of randomization until 100 months
Mortality
until the date of death from any cause until 100 months
- +3 more secondary outcomes
Study Arms (2)
INTERMITTENT ENTERAL NUTRITITION (IEN)
EXPERIMENTALAdministration 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 COMPARATORAdministration of Enteral Nutriton (EN) by nasogastric tube during 24 hours, using an infusion pump.
Interventions
Administration of Enteral Nutriton (EN) by nasogastric tube in 4 bolus (24h): Duration of the infusion 1hour each shot, using an infusion pump.
Administration of Enteral Nutriton (EN) by nasogastric tube during 24 hours, using an infusion pump.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Insulin dependent diabetic patients
- Abdominal surgery
- Dire prognosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maria Dolores Saiz Vinuesa
Albacete, 02008, Spain
Related 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.
PMID: 19372071BACKGROUNDLewis 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.
PMID: 29883514RESULTSinger 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.
PMID: 30348463RESULTPatel 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.
PMID: 29232262RESULTTavares 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.
PMID: 24559000RESULTSerpa 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.
PMID: 12754584RESULTIchimaru 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.
PMID: 29924423RESULTThong 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.
PMID: 34965317RESULTHeffernan 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.
PMID: 36284334RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M.Dolores Saiz-Vinuesa, NURSE
Gerencia de Atención Integrada de Albacete
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- By the nature of the intervention(intermittent or continuous administration of enteral nutrition) is impossible to mask it to participats, care provider or investigators.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 3, 2023
First Posted
May 30, 2023
Study Start
February 10, 2022
Primary Completion
February 29, 2024
Study Completion
April 30, 2024
Last Updated
May 30, 2023
Record last verified: 2023-05