Cargando…
Diabetes-Specific Formulae Versus Standard Formulae as Enteral Nutrition to Treat Hyperglycemia in Critically Ill Patients: Protocol for a Randomized Controlled Feasibility Trial
BACKGROUND: During critical illness, hyperglycemia is prevalent and is associated with adverse outcomes. While treating hyperglycemia with insulin reduces morbidity and mortality, it increases glycemic variability and hypoglycemia risk, both of which have been associated with an increase in mortalit...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5913570/ https://www.ncbi.nlm.nih.gov/pubmed/29631990 http://dx.doi.org/10.2196/resprot.9374 |
_version_ | 1783316568569020416 |
---|---|
author | Doola, Ra'eesa Todd, Alwyn S Forbes, Josephine M Deane, Adam M Presneill, Jeffrey J Sturgess, David J |
author_facet | Doola, Ra'eesa Todd, Alwyn S Forbes, Josephine M Deane, Adam M Presneill, Jeffrey J Sturgess, David J |
author_sort | Doola, Ra'eesa |
collection | PubMed |
description | BACKGROUND: During critical illness, hyperglycemia is prevalent and is associated with adverse outcomes. While treating hyperglycemia with insulin reduces morbidity and mortality, it increases glycemic variability and hypoglycemia risk, both of which have been associated with an increase in mortality. Therefore, other interventions which improve glycemic control, without these complications should be explored. Nutrition forms part of standard care, but the carbohydrate load of these formulations has the potential to exacerbate hyperglycemia. Specific diabetic-formulae with a lesser proportion of carbohydrate are available, and these formulae are postulated to limit glycemic excursions and reduce patients’ requirements for exogenous insulin. OBJECTIVE: The primary outcome of this prospective, blinded, single center, randomized controlled trial is to determine whether a diabetes-specific formula reduces exogenous insulin administration. Key secondary outcomes include the feasibility of study processes as well as glycemic variability. METHODS: Critically ill patients will be eligible if insulin is administered whilst receiving exclusively liquid enteral nutrition. Participants will be randomized to receive a control formula, or a diabetes-specific, low glycemic index, low in carbohydrate study formula. Additionally, a third group of patients will receive a second diabetes-specific, low glycemic index study formula, as part of a sub-study to evaluate its effect on biomarkers. This intervention group (n=12) will form part of recruitment to a nested cohort study with blood and urine samples collected at randomization and 48 hours later for the first 12 participants in each group with a secondary objective of exploring the metabolic implications of a change in nutrition formula. Data on relevant medication and infusions, nutrition provision and glucose control will be collected to a maximum of 48 hours post randomization. Baseline patient characteristics and anthropometric measures will be recorded. A 28-day phone follow-up will explore weight and appetite changes as well as blood glucose control pre and post intensive care unit (ICU) discharge. RESULTS: Recruitment commenced in February 2015 with an estimated completion date for data collection by May 2018. Results are expected to be available late 2018. CONCLUSIONS: This feasibility study of the effect of diabetes-specific formulae on the administration of insulin in critically ill patients and will inform the design of a larger, multi-center trial. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry (ANZCTR):12614000166673; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614000166673 (Archived by WebCite at http://www.webcitation.org/6xs0phrVu) |
format | Online Article Text |
id | pubmed-5913570 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-59135702018-05-03 Diabetes-Specific Formulae Versus Standard Formulae as Enteral Nutrition to Treat Hyperglycemia in Critically Ill Patients: Protocol for a Randomized Controlled Feasibility Trial Doola, Ra'eesa Todd, Alwyn S Forbes, Josephine M Deane, Adam M Presneill, Jeffrey J Sturgess, David J JMIR Res Protoc Original Paper BACKGROUND: During critical illness, hyperglycemia is prevalent and is associated with adverse outcomes. While treating hyperglycemia with insulin reduces morbidity and mortality, it increases glycemic variability and hypoglycemia risk, both of which have been associated with an increase in mortality. Therefore, other interventions which improve glycemic control, without these complications should be explored. Nutrition forms part of standard care, but the carbohydrate load of these formulations has the potential to exacerbate hyperglycemia. Specific diabetic-formulae with a lesser proportion of carbohydrate are available, and these formulae are postulated to limit glycemic excursions and reduce patients’ requirements for exogenous insulin. OBJECTIVE: The primary outcome of this prospective, blinded, single center, randomized controlled trial is to determine whether a diabetes-specific formula reduces exogenous insulin administration. Key secondary outcomes include the feasibility of study processes as well as glycemic variability. METHODS: Critically ill patients will be eligible if insulin is administered whilst receiving exclusively liquid enteral nutrition. Participants will be randomized to receive a control formula, or a diabetes-specific, low glycemic index, low in carbohydrate study formula. Additionally, a third group of patients will receive a second diabetes-specific, low glycemic index study formula, as part of a sub-study to evaluate its effect on biomarkers. This intervention group (n=12) will form part of recruitment to a nested cohort study with blood and urine samples collected at randomization and 48 hours later for the first 12 participants in each group with a secondary objective of exploring the metabolic implications of a change in nutrition formula. Data on relevant medication and infusions, nutrition provision and glucose control will be collected to a maximum of 48 hours post randomization. Baseline patient characteristics and anthropometric measures will be recorded. A 28-day phone follow-up will explore weight and appetite changes as well as blood glucose control pre and post intensive care unit (ICU) discharge. RESULTS: Recruitment commenced in February 2015 with an estimated completion date for data collection by May 2018. Results are expected to be available late 2018. CONCLUSIONS: This feasibility study of the effect of diabetes-specific formulae on the administration of insulin in critically ill patients and will inform the design of a larger, multi-center trial. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry (ANZCTR):12614000166673; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614000166673 (Archived by WebCite at http://www.webcitation.org/6xs0phrVu) JMIR Publications 2018-04-09 /pmc/articles/PMC5913570/ /pubmed/29631990 http://dx.doi.org/10.2196/resprot.9374 Text en ©Ra'eesa Doola, Alwyn S Todd, Josephine M Forbes, Adam M Deane, Jeffrey J Presneill, David J Sturgess. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.04.2018. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included. |
spellingShingle | Original Paper Doola, Ra'eesa Todd, Alwyn S Forbes, Josephine M Deane, Adam M Presneill, Jeffrey J Sturgess, David J Diabetes-Specific Formulae Versus Standard Formulae as Enteral Nutrition to Treat Hyperglycemia in Critically Ill Patients: Protocol for a Randomized Controlled Feasibility Trial |
title | Diabetes-Specific Formulae Versus Standard Formulae as Enteral Nutrition to Treat Hyperglycemia in Critically Ill Patients: Protocol for a Randomized Controlled Feasibility Trial |
title_full | Diabetes-Specific Formulae Versus Standard Formulae as Enteral Nutrition to Treat Hyperglycemia in Critically Ill Patients: Protocol for a Randomized Controlled Feasibility Trial |
title_fullStr | Diabetes-Specific Formulae Versus Standard Formulae as Enteral Nutrition to Treat Hyperglycemia in Critically Ill Patients: Protocol for a Randomized Controlled Feasibility Trial |
title_full_unstemmed | Diabetes-Specific Formulae Versus Standard Formulae as Enteral Nutrition to Treat Hyperglycemia in Critically Ill Patients: Protocol for a Randomized Controlled Feasibility Trial |
title_short | Diabetes-Specific Formulae Versus Standard Formulae as Enteral Nutrition to Treat Hyperglycemia in Critically Ill Patients: Protocol for a Randomized Controlled Feasibility Trial |
title_sort | diabetes-specific formulae versus standard formulae as enteral nutrition to treat hyperglycemia in critically ill patients: protocol for a randomized controlled feasibility trial |
topic | Original Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5913570/ https://www.ncbi.nlm.nih.gov/pubmed/29631990 http://dx.doi.org/10.2196/resprot.9374 |
work_keys_str_mv | AT doolaraeesa diabetesspecificformulaeversusstandardformulaeasenteralnutritiontotreathyperglycemiaincriticallyillpatientsprotocolforarandomizedcontrolledfeasibilitytrial AT toddalwyns diabetesspecificformulaeversusstandardformulaeasenteralnutritiontotreathyperglycemiaincriticallyillpatientsprotocolforarandomizedcontrolledfeasibilitytrial AT forbesjosephinem diabetesspecificformulaeversusstandardformulaeasenteralnutritiontotreathyperglycemiaincriticallyillpatientsprotocolforarandomizedcontrolledfeasibilitytrial AT deaneadamm diabetesspecificformulaeversusstandardformulaeasenteralnutritiontotreathyperglycemiaincriticallyillpatientsprotocolforarandomizedcontrolledfeasibilitytrial AT presneilljeffreyj diabetesspecificformulaeversusstandardformulaeasenteralnutritiontotreathyperglycemiaincriticallyillpatientsprotocolforarandomizedcontrolledfeasibilitytrial AT sturgessdavidj diabetesspecificformulaeversusstandardformulaeasenteralnutritiontotreathyperglycemiaincriticallyillpatientsprotocolforarandomizedcontrolledfeasibilitytrial |