Table 2 Study outcomes
Outcome | Definition |
|---|---|
Primary outcome | |
MAKE30 (primary outcome) | Major adverse kidney events at 30 days (defined as at least one of the following): • Death • New renal replacement therapy • Persistent kidney dysfunction at hospital discharge or 30 days (serum creatinine ≥2x baseline or median value for age if no baseline available and a minimum absolute increase of ≥0.3 mg/dL) |
Secondary effectiveness outcomes | |
Death | All-cause mortality at hospital discharge, 28 days, and 90 daysb |
Hospital length of stay | Days from hospital admission until discharge, censored at 90 days |
Hospital-free days out of 28 days | Days between enrollment and day 28 in which patient was alive and out of the hospital |
New inpatient renal replacement therapy | New continuous renal replacement therapy, hemodialysis, or peritoneal dialysis |
Persistent kidney dysfunction at hospital discharge | Serum creatinine ≥2x baseline or median value for age if no baselinea available, censored at 30 days |
Secondary safety outcomesc | |
Hyperlactatemia | > 4 mMol/L |
Hyperkalemia | > 6 mEq/L |
Hypercalcemia | Ionized calcium > 1.35 mmol/L or total serum calcium > 12 mg/dL |
Hypernatremia | > 155 mEq/L |
Hyponatremia | < 128 mEq/L |
Hyperchloremia | > 110 mEq/L |
Thrombosis | Therapy for new arterial or venous thrombus with systemic anticoagulant OR Clotting of intravenous catheter in subjects receiving ceftriaxone and lactated Ringer’s |
Cerebral edema | Therapy with hyperosmolar therapy (hypertonic saline and/or mannitol) for radiographic and clinical determination of new impending or present brain herniation |
Secondary biologic outcomesd | |
Urine neutrophil gelatinase-associated lipocalin | Biomarkers will be measured on the day of randomization (day 0), day 2, and day 27 (or prior to death or anticipated discharge, whichever comes first). Analyses will include between-group differences in absolute biomarker values at each timepoint and, to account for potential baseline differences, the percent change in biomarkers relative to measurements on study 0. |
Urine kidney injury molecular-1 | |
Urine liver-type fatty acid-binding protein | |
Urine interleukin-18 | |
Plasma cystatin C |