CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 157 enrolled
Drug / intervention
Lactated Ringer Solution +1 moredrug
Likely dose
Not stated in 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/NCT03133767
NCT03133767Phase 4Completed

Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation

Nicholas M Mohr·interventional·Posted Apr 28, 2017·Updated Sep 11, 2018

In Brief

A Phase 4 clinical trial evaluating Lactated Ringer Solution and Normal Saline 0.9% Infusion Solution Bag for Fluid Loss and 2 related conditions. Completed, enrolled 157 participants across 1 site.

Detailed Summary

Administration of intravascular (IV) fluid is the most common emergency department (ED) procedure. IV fluids are integral to increasing effective blood volume and ensuring organ perfusion in patients with volume depletion and dehydration. There are many options of IV fluids providers can use when treating ED patients. Surveys show physicians do not cite an evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to be influenced by type and location of practice. A gap exists in the current literature, as there is no evidence for the optimal IV fluid choice for the ED patient requiring IV fluid before discharge. Normal saline (NS) is commonly used as an IV fluid replacement in ED patients. However, NS has been associated with increased risk of acidosis and acute kidney injury. This study will use a novel approach of a patient-centered outcome in a non-critically ill population to ascertain the optimal IV fluid for patient quality of recovery. The results of this study will inform provider's IV fluid decisions between NS and LR. More importantly, the results of this study will have the power to improve patient's quality of recovery following IV fluid administration and subsequent ED discharge. ED patients will be recruited, and participants will be randomized to receive one of two IV solutions (Lactated ringer's or normal saline). Participants will answer a survey before and after the intervention to assess their quality of recovery. The post-survey will be administered by phone after ED discharge. Participants will also be contacted by text message one week following their ED visit to gather information on their healthcare utilization.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 28, 2017
Enrollment StartMay 23, 2017
Primary CompletionNov 1, 2017
Study CompletionNov 2, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.2 years ago

Interventions

Lactated Ringer Solutiondrug

2 liters of intravenous lactated ringers solution will be administered by peripheral IV

Normal Saline 0.9% Infusion Solution Bagdrug

2 liters of intravenous normal saline solution will be administered by peripheral IV