Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT03340805
Eligibility Criteria:
Inclusion Criteria:
1. Males or females age \>6 months to \<18 years
2. Clinician concern for septic shock, operationalized as:
1. a "positive" ED sepsis alert confirmed at the physician-led "sepsis huddle" OR
2. a physician diagnosis of suspected septic shock requiring parenteral antibiotics and fluid resuscitation as per the ED sepsis management pathway
3. administration of at least 20 mL/kg IV/ intraosseous (IO) fluid resuscitation
4. Receipt of ≤40 mL/kg IV/IO crystalloid fluid prior to randomization
5. Additional fluid deemed likely to be necessary to treat poor perfusion, defined as either hypotension or abnormal (either "flash" or \>2 second) capillary refill (as determined by clinician's judgment)10
6. Parental/guardian permission (informed consent) if time permits; otherwise, EFIC criteria met
Exclusion Criteria:
1. Clinician judgement that patient's condition deems it unsafe to administer either NS or LR (since patients will be equally likely to receive NS or LR at time of study enrollment), including (but not limited to):
1. Clinical suspicion for impending brain herniation based on data available at or before patient meets criteria for study enrollment
2. Known hyperkalemia, defined as non-hemolyzed whole blood or plasma/serum potassium \> 6 mEq/L, based on data available at or before patient meets criteria for study enrollment
3. Known hypercalcemia, defined as plasma/serum total calcium \>12 mg/dL or whole blood ionized calcium \> 1.35 mmol/L, based on data available at or before patient meets criteria for study enrollment
4. Known acute fulminant hepatic failure, defined as plasma/serum alanine aminotransferase (ALT) \>10,000 U/L or total bilirubin \>12.0 mg/dL, based on data available at or before patient meets criteria for study enrollment
5. Known history of severe hepatic impairment, defined as diagnosis of cirrhosis, "liver failure", or active listing for liver transplant
6. Known history of severe renal impairment, defined as current dependency on peritoneal dialysis or hemodialysis
7. Known metabolic disorder, inborn error of metabolism, or primary mineralcorticoid deficiency (e.g., mitochondrial disorder, urea cycle disorder, amino acidemia, fatty acid oxidation disorder, glycogen storage disorder, congenital adrenal hypoplasia, Addison's disease) as reported by subject, LAR or accompanying caregiver, or as listed in the medical record
2. Known pregnancy determined by routine clinical history disclosed by patient and/or legally authorized representative (LAR) (or other accompanying acquaintance)
3. Known prisoner as determined by routine social history disclosed by patient and/or LAR (or other accompanying acquaintance)
4. Known allergy to either normal saline or lactated Ringer's as determined by routine allergy history disclosed by patient and/or LAR (or other accompanying acquaintance) or as indicated in the medical record
5. Indication of prior declined consent to participate based on presence of "PRoMPT BOLUS Opt-Out" bracelet
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
17 Years
Study:
NCT03340805
Study Brief:
Protocol Section:
NCT03340805