Efficacy and Safety of the Implementation of an Algorithm for Enteral Nutrition Support.

NCT02740205 | Completed

• 1 other identifier: 1390
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to evaluate the efficacy and safety of the implementation of an Algorithm for enteral nutrition support compared with usual standard practice in non-critical hospitalized patients: ASNET algorithm.

Conditions

Malnutrition

Keywords

Patients with Enteral Feeding

Outcome Measures

Primary Outcomes (1)

• Adequacy of enteral nutrition

  The percentage of energy and proteins received by the patient trough tube feeds in contrast with the prescription

  4 days

Secondary Outcomes (1)

• Security variable

  30 days

Study Arms (2)

Control group

NO INTERVENTION

Hospital's standard EN support at the discretion of the Clinical Nutrition Service that is composed by physicians, dietitians, and students, provides nutritional assessments, recommendations and consultations for the in-patients that required nutrition support during their hospitalization stay. There is no protocols or algorithms for the nutritional support in our institution, the currently clinical practice of the EN is prescribed by the physician, dietitians and students during the morning rounds each 24h, the kind of EN formulas prescribed depends of the clinical status of the patient, when the patients required protein supplements modular protein supplements are added.

Algorithm for enteral nutrition support

EXPERIMENTAL

Initial infusion of 20 to 40 ml/h, evaluated the tolerability in the next 8-12h, then the infusion can be increased 25 ml/ 8-12h for gastric infusion and 10-20 ml/h for the post-pyloric feeding, for bolus infusion an initial infusion of 125 ml each 4-5hrs and evaluated the tolerability in the next 8-12h. If the subject present intolerability to the EN, the action in the algorithm indicate hold the infusion 4h then restarted at 10 ml/h with prokinetics agents rather than the suspension. As a part of the intervention, several educational sessions for the medical, nutritionist and nurse staff were performed during the period of the study.

Other: Algorithm for enteral nutrition support

Interventions

Algorithm for enteral nutrition support OTHER

Enteral nutrition support prescribed by the Clinical Nutrition Service under the instructions of the algorithm based on evidence

Also known as: Protocol for enteral nutrition support

Algorithm for enteral nutrition support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate to receive exclusively enteral nutrition
• Consent form signed

You may not qualify if:

• Patients in critical areas
• Carcinomatosis
• ICU admission
• Intestinal failure
• Receiving tube feeding prior to hospitalization

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico City, 14000, Mexico

Location

Related Publications (23)

• Mackenzie SL, Zygun DA, Whitmore BL, Doig CJ, Hameed SM. Implementation of a nutrition support protocol increases the proportion of mechanically ventilated patients reaching enteral nutrition targets in the adult intensive care unit. JPEN J Parenter Enteral Nutr. 2005 Mar-Apr;29(2):74-80. doi: 10.1177/014860710502900274.

  PMID: 15772383 BACKGROUND

• Kiss CM, Byham-Gray L, Denmark R, Loetscher R, Brody RA. The impact of implementation of a nutrition support algorithm on nutrition care outcomes in an intensive care unit. Nutr Clin Pract. 2012 Dec;27(6):793-801. doi: 10.1177/0884533612457178.

  PMID: 23135707 BACKGROUND

• Arabi Y, Haddad S, Sakkijha M, Al Shimemeri A. The impact of implementing an enteral tube feeding protocol on caloric and protein delivery in intensive care unit patients. Nutr Clin Pract. 2004 Oct;19(5):523-30. doi: 10.1177/0115426504019005523.

  PMID: 16215149 BACKGROUND

• Heyland DK, Cahill NE, Dhaliwal R, Wang M, Day AG, Alenzi A, Aris F, Muscedere J, Drover JW, McClave SA. Enhanced protein-energy provision via the enteral route in critically ill patients: a single center feasibility trial of the PEP uP protocol. Crit Care. 2010;14(2):R78. doi: 10.1186/cc8991. Epub 2010 Apr 29.

  PMID: 20429886 BACKGROUND

• Ventura AM, Waitzberg DL. Enteral nutrition protocols for critically ill patients: are they necessary? Nutr Clin Pract. 2015 Jun;30(3):351-62. doi: 10.1177/0884533614547765. Epub 2014 Sep 23.

  PMID: 25249598 BACKGROUND

• Martin CM, Doig GS, Heyland DK, Morrison T, Sibbald WJ; Southwestern Ontario Critical Care Research Network. Multicentre, cluster-randomized clinical trial of algorithms for critical-care enteral and parenteral therapy (ACCEPT). CMAJ. 2004 Jan 20;170(2):197-204.

  PMID: 14734433 BACKGROUND

• Heyland DK, Cahill N, Day AG. Optimal amount of calories for critically ill patients: depends on how you slice the cake! Crit Care Med. 2011 Dec;39(12):2619-26. doi: 10.1097/CCM.0b013e318226641d.

  PMID: 21705881 BACKGROUND

• Taylor B, Brody R, Denmark R, Southard R, Byham-Gray L. Improving enteral delivery through the adoption of the "Feed Early Enteral Diet adequately for Maximum Effect (FEED ME)" protocol in a surgical trauma ICU: a quality improvement review. Nutr Clin Pract. 2014 Oct;29(5):639-48. doi: 10.1177/0884533614539705.

  PMID: 25155862 BACKGROUND

• Bowman A, Greiner JE, Doerschug KC, Little SB, Bombei CL, Comried LM. Implementation of an evidence-based feeding protocol and aspiration risk reduction algorithm. Crit Care Nurs Q. 2005 Oct-Dec;28(4):324-33; quiz 334-5. doi: 10.1097/00002727-200510000-00004.

  PMID: 16239821 BACKGROUND

• Woien H, Bjork IT. Nutrition of the critically ill patient and effects of implementing a nutritional support algorithm in ICU. J Clin Nurs. 2006 Feb;15(2):168-77. doi: 10.1111/j.1365-2702.2006.01262.x.

  PMID: 16422734 BACKGROUND

• Martins JR, Shiroma GM, Horie LM, Logullo L, Silva Mde L, Waitzberg DL. Factors leading to discrepancies between prescription and intake of enteral nutrition therapy in hospitalized patients. Nutrition. 2012 Sep;28(9):864-7. doi: 10.1016/j.nut.2011.07.025. Epub 2011 Nov 25.

  PMID: 22119484 BACKGROUND

• Lottes Stewart M. Nutrition support protocols and their influence on the delivery of enteral nutrition: a systematic review. Worldviews Evid Based Nurs. 2014 Jun;11(3):194-9. doi: 10.1111/wvn.12036. Epub 2014 May 19.

  PMID: 24841717 BACKGROUND

• Cahill NE, Murch L, Cook D, Heyland DK; Canadian Critical Care Trials Group. Improving the provision of enteral nutrition in the intensive care unit: a description of a multifaceted intervention tailored to overcome local barriers. Nutr Clin Pract. 2014 Feb;29(1):110-7. doi: 10.1177/0884533613516512. Epub 2013 Dec 16.

  PMID: 24344255 BACKGROUND

• Peev MP, Yeh DD, Quraishi SA, Osler P, Chang Y, Gillis E, Albano CE, Darak S, Velmahos GC. Causes and consequences of interrupted enteral nutrition: a prospective observational study in critically ill surgical patients. JPEN J Parenter Enteral Nutr. 2015 Jan;39(1):21-7. doi: 10.1177/0148607114526887. Epub 2014 Apr 7.

  PMID: 24714361 BACKGROUND

• Heyland DK, Cahill NE, Dhaliwal R, Sun X, Day AG, McClave SA. Impact of enteral feeding protocols on enteral nutrition delivery: results of a multicenter observational study. JPEN J Parenter Enteral Nutr. 2010 Nov-Dec;34(6):675-84. doi: 10.1177/0148607110364843.

  PMID: 21097768 BACKGROUND

• Langkamp-Henken B. If the gut works, use it: but what if you can't? Nutr Clin Pract. 2003 Dec;18(6):449-50. doi: 10.1177/0115426503018006449. No abstract available.

  PMID: 16215080 BACKGROUND

• Barr J, Hecht M, Flavin KE, Khorana A, Gould MK. Outcomes in critically ill patients before and after the implementation of an evidence-based nutritional management protocol. Chest. 2004 Apr;125(4):1446-57. doi: 10.1378/chest.125.4.1446.

  PMID: 15078758 BACKGROUND

• Braunschweig CL, Levy P, Sheean PM, Wang X. Enteral compared with parenteral nutrition: a meta-analysis. Am J Clin Nutr. 2001 Oct;74(4):534-42. doi: 10.1093/ajcn/74.4.534.

  PMID: 11566654 BACKGROUND

• Heyland DK, Dhaliwal R, Wang M, Day AG. The prevalence of iatrogenic underfeeding in the nutritionally 'at-risk' critically ill patient: Results of an international, multicenter, prospective study. Clin Nutr. 2015 Aug;34(4):659-66. doi: 10.1016/j.clnu.2014.07.008. Epub 2014 Jul 19.

  PMID: 25086472 BACKGROUND

• Baca Molina GP, Pena Corona M. [Prevalence of enteral patients with suboptimal feeding at Centro Medico Lic. Adolfo Lopez Mateos]. Nutr Hosp. 2015 Apr 1;31(4):1597-602. doi: 10.3305/nh.2015.31.4.8353. Spanish.

  PMID: 25795946 BACKGROUND

• MacLaren R. Intolerance to intragastric enteral nutrition in critically ill patients: complications and management. Pharmacotherapy. 2000 Dec;20(12):1486-98. doi: 10.1592/phco.20.19.1486.34853.

  PMID: 11130221 BACKGROUND

• Kim H, Stotts NA, Froelicher ES, Engler MM, Porter C. Why patients in critical care do not receive adequate enteral nutrition? A review of the literature. J Crit Care. 2012 Dec;27(6):702-13. doi: 10.1016/j.jcrc.2012.07.019. Epub 2012 Oct 17.

  PMID: 23084129 BACKGROUND

• Ortiz-Reyes LA, Castillo-Martinez L, Lupian-Angulo AI, Yeh DD, Rocha-Gonzalez HI, Serralde-Zuniga AE. Increased Efficacy and Safety of Enteral Nutrition Support with a Protocol (ASNET) in Noncritical Patients: A Randomized Controlled Trial. J Acad Nutr Diet. 2018 Jan;118(1):52-61. doi: 10.1016/j.jand.2017.09.020.

  PMID: 29274643 DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Algorithms; Clinical Protocols

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Mathematical Concepts; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Aurora E Serralde-Zúñiga, MD,PhD

  Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 15, 2016
• Study Start: October 1, 2014
• Primary Completion: August 13, 2020
• Study Completion: August 13, 2020
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)