CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
Lactated Ringer +1 moredrug
Likely dose
Lactated Ringer 100 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03340805
NCT03340805Phase 1Completed
CompareCT.gov

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: A Pilot Feasibility Study

Children's Hospital of Philadelphia·interventional·Posted Nov 14, 2017·Updated Aug 5, 2019

In Brief

A Phase 1 clinical trial evaluating Lactated Ringer and Normal saline for Shock, Septic. Completed, enrolled 50 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShock, Septic
CountriesUnited States
CollaboratorsUniversity of Utah, University of Pennsylvania, University of California, Davis

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedNov 14, 2017
Enrollment StartJan 24, 2018
Primary CompletionAug 31, 2018
Study CompletionJan 15, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.6 years ago

Interventions

Lactated Ringerdrug

LR is a sterile, nonpyrogenic "balanced" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).

Normal salinedrug

Normal saline solution is an "unbalanced" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.