Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation

Emergencies Clinical Trial

Official title:

Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133767
• Other study ID #: 201701764
• Status: Completed
• Phase: Phase 4
• Start date: May 23, 2017
• Est. completion date: November 2, 2017

Study information

• Verified date: August 2018
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 Surveys show physicians do not cite an evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to be influenced by type and location of practice.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

Description:

This is a single-center randomized, single-blinded, controlled clinical trial testing superiority of LR compared to NS in patients receiving IV fluid before discharge.

The study site is the University of Iowa Emergency Department (annual patient volume is 60,000 patients/year).

The study population will include adult ED patients presenting with chief complaints associated with volume depletion. Figure 1 outlines the enrollment flowchart for the study with inclusion and exclusion criteria. Research assistants (RAs) are available in the ED from 9am - 10pm every day, and an automated paging system will alert the team when patients qualify, as the study team has done previously. All participants will receive 2 liters of blinded IV fluid as part of the study. The intervention group will receive lactated ringer's, and the control group will receive normal saline (0.9% sodium chloride). Nursing staff will establish the peripheral IV access, and subjects will be blinded to group.

The primary outcome, Quality of Recovery-40, will be analyzed using a t-test (if parametric) or Mann Whitney U Test (non-parametric) in an intention-to-treat (ITT) analysis. Normality will be assessed with a Kolmogorov-Smirnov (K-S) and visualization of data. Due to the nature of time-critical emergency department research, an additional analysis will be done by treatment received and compared to the primary ITT analysis as a sensitivity analysis. Secondary outcomes will be reported as a relative risk with 95%CI in an ITT analysis. A safety analysis of secondary outcomes will be performed by treatment received (see page 37). Baseline characteristics will be reported with summary statistics as appropriate (mean, SD, median, IQR) and differences in characteristics will be conducted using a t-test and chi-square test, as appropriate. The following variables will also be assessed: actual fluid administered(mL), pre-intervention QoR-40 score, and time from intervention to primary outcome. If differences in these characteristics exist between the control and intervention groups, multivariate linear regression and multivariate logistic regression (primary and secondary outcomes, respectively) will be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: November 2, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behcet Syndrome
• Emergencies
• Fluid Loss
• Symptom Complex, Triple

Intervention

Drug:
• Lactated Ringer Solution
2 liters of intravenous lactated ringers solution will be administered by peripheral IV
• Normal Saline 0.9% Infusion Solution Bag
2 liters of intravenous normal saline solution will be administered by peripheral IV

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Nicholas M Mohr

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery-40 Score at 24 Hours	The Quality of Recovery-40 (QoR-40) is a validated instrument that quantifies patient's self-assessment of functional recovery, symptoms, and physical comfort. The QoR-40 scores range from 40 to 200 with a 200 representing a better recovery outcome. The survey consists of 40 questions scored from one to five with a Likert scale, and the total score is the sum of each question.	24 hours after ED visit
Secondary	Quality of Recovery-40 Score After Administration	The Quality of Recovery-40 (QoR-40) is a validated instrument that quantifies patient's self-assessment of functional recovery, symptoms, and physical comfort. The QoR-40 scores range from 40 to 200 with a 200 representing a better recovery outcome. The survey consists of 40 questions scored from one to five with a Likert scale, and the total score is the sum of each question.	Immediately after fluid administration
Secondary	Number of Participants That Filled an ED Prescription	Seven days after study enrollment, participants were asked by text message, "Have you filled any prescriptions from the emergency department?"	7 days after study enrollment
Secondary	Number of Participants That Returned to the ED Within 7 Days for the Same Complaint	Seven days after study enrollment, participants were asked by text message, "Have you returned to the emergency department for the same problem?"	7 days
Secondary	Participants That Sought Care From Another Healthcare Provider for the Same Complaint	Seven days after study enrollment, participants were asked by text message, "Have you seen another medical provider for the same complaint?".	7 days