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Table 2 Study outcomes

From: PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial

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
  1. aBaseline creatinine will be determined for each study participant as the lowest recorded creatinine available between 12 months and 24 h prior to the index admission. For participants without such data available, an estimated baseline creatinine will be imputed using previously established median values for age and sex
  2. bMortality at 90 days will be measured using vital status obtained from the medical record at all sites, as well as the US National Death Index and Canadian provincial vital statistics if vital status cannot be confirmed using medical records alone
  3. cSafety outcomes must occur within 4 calendar days of randomization, except thrombosis which must occur within 7 days of randomization
  4. dPlasma and urine biomarkers of kidney injury will also be collected from study participants enrolled at a subset of sites