Target study sample size
hyperhydration, HUS
EVENT, COMPLICATIONS, SECONDARY
We estimate the overall study sample size required is 1040. The number to be screened will likely be 25% higher given that some children will be ineligible, and some will decline consent. Preliminary data indicate that the primary outcome event rate in the conservative fluid management arm will be approximately 10%. The study will be powered to detect a 5% absolute reduction (risk ratio 0.5) in the rate of MAKE30 in the hyperhydration arm. Using a conservative estimate of 5–15 subjects per year per site, we used simulated data (R software) to generate a power table (Table Power calculations for the primary outcome
The anticipated HUS rate in the conservative fluid management arm is 17.5%, and the rate of extrarenal complications is 7.5%. Detectable absolute differences for these two outcomes with 80% and 90% power, at approximately the same ICC as estimated for the primary outcome, are provided (Table Power calculations for secondary outcomes