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Table 3 Patient characteristics

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

Characteristic 0.9% saline Balanced/buffered fluid
  (n = ) (n = )
Country of enrollment, n (%)   
 USA   
 Canada   
 Australia/New Zealand   
Age in years, median (IQR)   
Age category, n (%)   
 6 mos to < 1 year   
 1 year to < 5 years   
 5 years to < 12 years   
 12 years to < 18 years   
Sex, n (%)   
 Male   
 Female   
 Other/unknown   
Race, n (%)   
 White   
 Black   
 Asian   
 American Indian/Alaska Native   
 Native Hawaiian/Other Pacific Islander   
 Unknown/not reporteda   
Ethnicity, n (%)   
 Hispanic or Latino   
 Aboriginal or Torres Strait Islander   
 Maori   
 Otherb   
 Unknown/not reporteda   
Weight (kg), median (IQR)   
Comorbid conditions, n (%)   
 Cancer (hematogenous or solid tumor)   
 Bone marrow or solid organ transplant   
 Cardiomyopathy or heart failure   
 Pulmonary hypertension   
 Kidney disease (not on dialysis)   
 Neurologic dysfunction causing severe developmental delay   
 Sickle cell disease   
 Chronic ventilator dependence   
 Indwelling central line   
Site of infection, n (%)   
 Primary bloodstream   
 Pneumonia or other lung infections   
 Abdominal   
 Genitourinary   
 Central nervous system   
 Skin/soft tissue   
 Other infection   
 Unknown site   
 Alternative diagnosis (not infection)   
Positive blood culture (bacteremia) as either primary or additional site of infection, n (%)   
Concurrent Therapies (through study day 1, 11:59 pm)   
 Antibiotics prior to study site ED arrival, n (%)   
 Minutes to first antibiotic administration after ED arrival, median (IQR)c   
 Ceftriaxone, n (%)   
 Vasoactives, n (%)   
 Corticosteroids, n (%)   
 Bicarbonate or other buffers, n (%)   
 Invasive mechanical ventilationd, n (%)   
 Extracorporeal membrane oxygenation, n (%)   
Baseline creatinine (mg/dL)e, median (IQR)   
KDIGO acute kidney injury stage at enrollment, n (%)   
 Stage 1   
 Stage 2   
 Stage 3   
  1. KDIGO, Kidney Disease: Improving Global Outcomes
  2. aRace and ethnicity not available from participants enrolled in Canadian sites
  3. b“Other” ethnicity includes participants who identified as not Hispanic or Latino in the USA and not Aboriginal or Torres Strait Islander or Maori in Australia/New Zealand
  4. cIncludes only the subset of participants (n = ) who did not receive antibiotics prior to study site ED arrival
  5. dIncludes only invasive mechanical ventilation delivered through an endotracheal tube (oral or nasal), tracheostomy, laryngeal mask airway, or other invasive devices
  6. eBaseline serum creatinine is the lowest creatinine available between 12 months and 24 h prior to study enrollment or, for participants without such data, an imputed value using established median values for age and sex
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