01 Feb Sample size expansion of the ESSENTIAL trial
Sample size expansion of the ESSENTIAL trial
Considering the latest findings in the EFFORT-Protein trial that higher protein delivery might be harmful to patients with AKI, the ESSENTIAL trial revised the eligible criteria on March 4th 2023, expanding the exclusion criteria from the original version of AKI stage III patients to all AKI patients. According to the Statistical Analysis Plan, the primary analysis of the ESSENTIAL trial will be based on a modified Intention To Treat analysis for efficacy which will only involve all the randomized patients without AKI. As a result, 88 patients enrolled before this modification did not meet the updated eligibility criteria, and therefore will be excluded from the primary analysis. To maintain the statistical power, the ESSENTIAL trial will expand the targeted sample size from 1838 to 1928. All these changes have been approved by the Ethics Committees.
ESSENTIAL Trial Management Committee
February 1st 2024