Table 2.
Advantages and disadvantages of several common AKI trial outcome measures
| End Point | Advantages | Disadvantages |
|---|---|---|
| AKI | • Sensitive (frequent) end point and thus may support smaller sample sizes • Associated with mortality and other organ dysfunction |
• Has been inconsistently associated with worse clinical outcomes (e.g., death) |
| Severe AKI | • Indicative of kidney damage • Associated with mortality, increased costs, hospital length of stay, and other measures of healthcare utilization |
• As a less frequently occurring event, may require larger sample size |
| Change in GFR | • Sensitive (frequent) end point and thus may support smaller sample sizes • Commonly collected value |
• Not a patient-centered outcome • Requires accurate measurement • Multiple possible ways to measure |
| Renal recovery | • Sensitive (frequent) end point and thus may support smaller sample sizes • Associated with mortality and morbidity |
• Variable definitions are used in practice, making across-trial comparisons potentially difficult |
| CKD | • Associated with mortality, morbidity, increased costs, and cardiovascular disease • Patient-centered outcome |
• Rare end point • Requires long-term follow-up to capture • Requires accurate measurement |
| RRT | • Associated with mortality, morbidity, and resource utilization | • Indications vary between institutions and providers; use of RRT is a clinical decision and not a pathophysiologic entity per se • Susceptible to survivorship bias |
| All-cause mortality | • Hard, patient-centered outcome • Easy to capture |
• Cause of death may not directly result from AKI • As a less frequently occurring event, may require larger sample size |
| MAKE at 90 days | • Occurs more frequently than individual component events | • May be driven by death and not directly related to AKI • Components may not be equally valued by different stakeholders • Low incidence in certain populations |
| Cardiovascular events | • Associated with kidney injury • Associated with mortality • Patient-centered outcome |
• May not directly result from AKI • Susceptible to survivorship bias |
This table is partially adapted from ref. 55, with permission.