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Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation

NCT03133767 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2018-09-11

Study results available
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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 Surveys show physicians do not cite an evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to be influenced by type and location of practice.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.

Conditions

  • Fluid Loss
  • Symptom Complex, Triple
  • Emergencies

Interventions

DRUG

Lactated Ringer Solution

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

DRUG

Normal Saline 0.9% Infusion Solution Bag

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

Sponsors & Collaborators

  • Nicholas M Mohr

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-23
Primary Completion
2017-11-01
Completion
2017-11-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03133767 on ClinicalTrials.gov