01 Sep EffectiveNess of feEding protocol on nutritional thErapy and clinical outcomes in critically ill patients: a multi-centered, cluster-ranDomized, parallel-controlled Trial
Registered ID: ISRCTN12233792
Study design: a multi-centered, cluster-randomized, parallel-controlled trial
Trial status: recruitment completed
Overall trial start date: 26/12/2016
Overall trial end date: 28/12/2019
Recruitment start date: 26/3/2018
Recruitment end date: 04/07/2019
In the intensive care unit (ICU), nutritional therapy is one of the most crucial treatment for critically ill patients which may significantly influence the clinical outcomes. There is a large body of evidence showing that malnutrition is associated with significantly increased risk of death. Besides, ICU patients are at increased risk of underfeeding, which could further exacerbate the existing gap between energy demand and intake. The route of nutrition delivery is another important issue when starting nutritional therapy for ICU patients. Enteral feeding has been repeatedly proven to be superior over parenteral nutrition (PN) with respect to the clinical outcomes such as nosocomial infection and mortality.
China has one of the largest critically ill population in the world, and the clinical practice of EN feeding varies massively. Previous small studies have shown that the proportion of EN was as low as 40% on day 2, which could be improved with the implementation of EN feeding protocol.However, to the best of our knowledge, there is a lack of large-scale data on the practice of enteral nutrition in ICUs.
Cluster randomized method can effectively control the confounding factors between groups to obtain more reliable conclusions. In addition, patient-levelrandomization would inevitably lead to pollution effect as the feeding protocol in the study group would always affect the clinical practice in the controls. Randomization at the hospital level and stratification could help avoid pollution.
Therefore, we conduct a multi-centered, cluster-randomized, parallel-controlled trial to assess the effect of a feeding protocol on nutritional therapy and clinical outcome in critically ill patients. The present clinical interventional study will be performed in 97 different ICUs across China with different clinical settings including surgical ICU, medical ICU, neurological ICU, etc. Randomization will occur in a 1:1 fashion for the participating centers within the same category with computer-generated random numbers and all the randomization will be once completed. Allocation concealment was maintained by conducting randomization after consent to participate was obtained.