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Phase 4 N=157 Randomized Double-blind Treatment

Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation

Fluid Loss · Symptom Complex, Triple · Emergencies

Enrolled (actual)
157
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Quality of Recovery-40 Score at 24 Hours — 166.8; 164.4 units on a scale — p=0.608

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Lactated Ringer Solution (Drug); Normal Saline 0.9% Infusion Solution Bag (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Nicholas M Mohr
Primary completion
Nov 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Quality of Recovery-40 Score at 24 Hours
166.8; 164.4 0.608
SECONDARY
Quality of Recovery-40 Score After Administration
152.6; 141.6 0.027 sig
SECONDARY
Number of Participants That Filled an ED Prescription
14; 19 0.202
SECONDARY
Number of Participants That Returned to the ED Within 7 Days for the Same Complaint
5; 7 0.361
SECONDARY
Participants That Sought Care From Another Healthcare Provider for the Same Complaint
9; 7 0.509

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 Surveys show physicians do not cite an evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to be influenced by type and location of practice.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

Eligibility Criteria

Inclusion Criteria

  • Emergency department patient
  • Chief complaint of nausea, vomiting or emesis, diarrhea, abdominal pain, dehydration, heat stroke or exhaustion
  • ED provider approves administration of two liters of fluid
  • ED provider states patient is likely to be discharged
  • Patient has followed up with PCP in the last two years
  • Patient has access to phone for next two days following ED discharge

Exclusion Criteria

  • Prisoners
  • Children
  • Women known to be pregnant
  • Jaundice
  • Current chemotherapy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03133767). 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.

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