Skip to main content

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