Phase 1
N=50
Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: A Pilot Feasibility Study
Shock, Septic
Bottom Line
View on ClinicalTrials.gov: NCT03340805 ↗Enrolled (actual)
50
Serious AEs
12.0%
Results posted
Aug 2019
Primary outcome: Primary: Compliance With Study Fluid Administration in the Assigned Study Arm — 0; 100 Proportion of total crystalloids adminis
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Lactated Ringer (Drug); Normal saline (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compliance With Study Fluid Administration in the Assigned Study Arm |
0; 100 | — |
| SECONDARY Enrollment of Eligible Patients |
50 | — |
| SECONDARY Acceptability of Enrollment Using "Exception From Informed Consent" |
43 | — |
Summary
The objective of this pilot study is to assess overall feasibility prior to embarking on a larger randomized pragmatic trial comparing the clinical effectiveness of fluid resuscitation with NS versus LR for pediatric patients with suspected septic shock. Necessary feasibility assessments include ensuring appropriate compliance with study fluid in each of the two arms, effectiveness of study enrollment using a pragmatic study design embedded within routine clinical practice, and acceptability of using Exception from Informed Consent (EFIC).
Eligibility Criteria
Inclusion Criteria
- Males or females age >6 months to 2 second) capillary refill (as determined by clinician's judgment)10
- Parental/guardian permission (informed consent) if time permits; otherwise, EFIC criteria met
Exclusion Criteria
- 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):
- Clinical suspicion for impending brain herniation based on data available at or before patient meets criteria for study enrollment
- 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
- 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
- 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
- Known history of severe hepatic impairment, defined as diagnosis of cirrhosis, "liver failure", or active listing for liver transplant
- Known history of severe renal impairment, defined as current dependency on peritoneal dialysis or hemodialysis
- 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
- Known pregnancy determined by routine clinical history disclosed by patient and/or legally authorized representative (LAR) (or other accompanying acquaintance)
- Known prisoner as determined by routine social history disclosed by patient and/or LAR (or other accompanying acquaintance)
- 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
- Indication of prior declined consent to participate based on presence of "PRoMPT BOLUS Opt-Out" bracelet
Data sourced from ClinicalTrials.gov (NCT03340805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.