Phase 4
N=157
Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation
Fluid Loss · Symptom Complex, Triple · Emergencies
Bottom Line
View on ClinicalTrials.gov: NCT03133767 ↗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
| Outcome | Result | p-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 Surveys show physicians do not cite an evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to be influenced by type and location of practice.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
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.