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

Malnutrition Clinical Trial

Official title:

Efficacy and Safety of the Implementation of an Algorithm for Enteral Nutrition Support Compared With Traditional Practice in Non-critical Patients: Randomized Clinical Trial, Simple Blind.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02740205
• Other study ID #: 1390
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: August 13, 2020

Study information

• Verified date: March 2022
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The algorithms for the enteral nutrition support also called protocols had been developed and implemented in the intensive care units (ICU) across the world to enhance the provision of calories and proteins via enteral nutrition (EN), increasing the proportion of patients that received an optimal amount (80-85% of their energy and protein requirements), and decreasing the caloric and protein debt. The algorithm includes different designs and interventions, the variability of the design is because the algorithm is adapted to the local necessities.

The principal reason for the algorithm implementation is the rate of underfed (receiving <80% of prescribed of energy and protein requirements) as a result of numerous causes 26% considered avoidable events, and the variation of the clinical practice. There's a universal consensus that the EN is the principal artificial way for the macro-micro nutrients delivery, it comes with the novelty "if the gut works, use it or prepare to lose it". The evidence shows that the EN is more physiological and when the patients received the optimal amount of EN the clinical outcomes (length of hospital stay, mortality and infection rates) can decrease significantly. In average 74% of the patients in the ICU that received EN are underfed, in Mexico 71% of the hospitalized patients with EN in non-critical areas are underfed, receiving only 61% of their energy requirements during their hospitalization.

The investigators propose an algorithm for the EN support based on evidence, in order to avoid the variability in the prescription that include a prediction equation according to the BMI to calculate the energy and protein requirements. The algorithm propose the range for the initial infusion for the gastric and post-pyloric feeding in continuous infusion and evaluated the tolerability, if there is no signs and symptoms of intolerance then the infusion can be increased. If the subject present intolerability to the EN (diarrhea, abdominal distention), an action in the algorithm indicate options rather than the suspension. Moreover when the EN is interrupt for a reason that is not intolerance and only if the patient already reach the goal rate the compensatory feed table can be use it. As a part of the intervention, several educational sessions for the medical, nutritionist and nurse staff were performed during the period of the study.

The investigators hypothesize that the implementation of the algorithm for EN support will increase the amount of energy and protein safely and effectively to the patients compared with the usual practice.

The purpose of this study is to evaluate the efficacy and safety of the implementation of an algorithm for EN support (ASNET).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 13, 2020
• Est. primary completion date: August 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Candidate to receive exclusively enteral nutrition

• Consent form signed

Exclusion Criteria:

• Patients in critical areas

• Carcinomatosis

• ICU admission

• Intestinal failure

• Receiving tube feeding prior to hospitalization

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• Algorithm for enteral nutrition support
Enteral nutrition support prescribed by the Clinical Nutrition Service under the instructions of the algorithm based on evidence

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	México	Ciudad De México

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (22)

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. — View Citation

Baca Molina GP, Peña 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Langkamp-Henken B. If the gut works, use it: but what if you can't? Nutr Clin Pract. 2003 Dec;18(6):449-50. — View Citation

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. — View Citation

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. Erratum in: JPEN J Parenter Enteral Nutr. 2005 Jul-Aug;29(4):xii. — View Citation

MacLaren R. Intolerance to intragastric enteral nutrition in critically ill patients: complications and management. Pharmacotherapy. 2000 Dec;20(12):1486-98. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Wøien H, Bjørk 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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Security variable	The rate of gastrointestinal complications: diarrhea (>500cc), abdominal distention, emesis.	30 days