Clinical trial NCT03133767
Conditions: Fluid Loss Symptom Complex, Triple Emergencies
Keywords: Normal saline Lactated ringers Emergency department
Sponsor: Nicholas M Mohr
Start date: 2017-05-23; Completion date: 2017-11-02
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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 Surveys show physicians do not cite an evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to be influenced by type and location of practice.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

Detailed 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.

Arms: arm 1: Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay arm 2: Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay
Interventions: intervention 1: Lactated Ringer Solution intervention 2: Normal Saline 0.9% Infusion Solution Bag
Intervention descriptions: intervention 1: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV intervention 2: 2 liters of intravenous normal saline solution will be administered by peripheral IV

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
 
 
STUDY PROTOCOL 
 
Saline vs. Lactated Ringers for 
Emergency Department IV Fluid 
Resuscitation 
 
NCT03133767 
Date Created: 03/15/17 
Date Uploaded: 06/26/18 
 
 
 
 


PROTOCOL: Comparison of Lactated Ringer’s and Normal Saline IV Fluids for Quality of Recovery in the 
Stable Emergency Patient  
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A. Introduction 
A.1. Health Problem Needing Intervention and Impact of 
Proposed Intervention 
Administration of intravascular (IV) fluid is the most common emergency department 
(ED) procedure1.  IV fluids are integral to increasing effective blood volume and ensuring 
organ perfusion in patients with volume depletion and dehydration2.  There are many 
options of IV fluids providers can use when treating ED patients3.  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 practice4,5.  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 patients6. 
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. 
 
B. Background 
B.1. Prior Literature and Studies 
Common IV fluids used for ED patients are normal saline (NS), a 0.9% sodium chloride 
solution, and lactated ringer’s (LR), another isotonic saline solution3.  There is a wealth 
of literature competing IV crystalloid solutions, like NS and LR, among others7-9, yet 
administration of LR and NS by ED providers remains heterogeneous for non-critical ED 
patients.   
 
NS has been shown to decrease renal arterial blood flow in healthy volunteers10.  Large 
animal studies support the finding of increased metabolic acidosis and also cite 
hyperkalemia in subjects receiving NS, when compared to LR11.  Increased risk of 
acidosis is most likely due to high chloride concentration3,6.  LR is one of the “low-
chloride” crystalloid solutions with a chloride load that is physiologic, or similar to the 
amount of chloride in human serum.  While other low-chloride solutions have not been 
associated significantly different AKI or mortality than NS12, observational studies have 
identified a protective association of LR for acute kidney injury and hospital mortality in 
critically-ill patients when compared to NS13,14.  A recent meta-analysis found an 
association between high-chloride IV solutions, including NS, and inferior clinical 
outcomes7, but no studies included an outcome of quality of recovery.  
 
This study proposes comparing LR and NS in a non-critically ill population, ED patients 
receiving fluid before discharge.  ED patients presenting with chief complaints likely to 
be associated with dehydration or volume depletion (nausea, vomiting or emesis, 
diarrhea, dehydration, heat stroke or exhaustion, and/or abdominal pain) will be 
included.  One previous study has compared LR and NS in patients with severe diarrhea 
and was stopped for efficacy when LR corrected pH in subjects more quickly than NS15. 


PROTOCOL: Comparison of Lactated Ringer’s and Normal Saline IV Fluids for Quality of Recovery in the 
Stable Emergency Patient  
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This study will add to the current literature with a comparison of LR to NS on a patient-
centered outcome for the most common procedure in emergency department patient 
populations. 
B.2. Rationale for this Study 
This is the first study to investigate the patient-centered outcome, quality of recovery, in 
a trial comparing LR and NS in an ED population stable for discharge.  Previous studies 
indicate there could be an improved patient recovery when patients receive LR solution 
compared to NS solution as an IV fluid.  Quality of recovery will be assessed by patient 
assessment of Comfort, Emotion, Physical Independence, Patient Support, and Pain.  
 
Results from the proposed study could increase patient recovery at little or no increased 
cost.  Normal saline and lactated ringer’s solutions (1000 ml or CC) are similar costs 
(1.485 and 1.304 Payment Limits, respectively)16, and both are readily available in most 
hospital formularies.  This study proposes comparing two readily-available, low-cost IV 
fluids on the basis of patient-reported quality of recovery in patients discharged from the 
ED.  
 
The study hypothesis is emergency department patients receiving lactated ringer’s 
solution will have an improved Quality of Recovery when compared patients receiving 
normal saline. 
 
C. Study Objectives 
C.1. Primary Aim 
The primary objective of this study is to compare the quality of recovery in ED patients 
receiving lactated ringer’s and normal saline IV solutions at 24 hours after ED discharge. 
C.2. Secondary Aim 
The secondary aim of the study is to describe differences in healthcare utilization after 
ED discharge between subjects in the control NS and intervention LR groups. 
 
D. Study Design  
D.1. Overview & Design Summary 
 
This is a single-blind, randomized controlled trial in a single Midwestern emergency 
department with 60,000 patient visits per year.  Enrollment of 156 subjects is planned. 
Subjects will be randomized to receive a single administration of two liters of either 
normal saline or lactated ringer’s solution.  Evaluations will occur at baseline, one day 
following ED discharge, and seven days following ED discharge. 
 
Potential participants will be screened upon ED registration.  Subjects will participate in 
study for seven days (during ED visit with two remote follow-up contacts at one and 
seven days).  Total duration of the study is expected to be 12 weeks. 


PROTOCOL: Comparison of Lactated Ringer’s and Normal Saline IV Fluids for Quality of Recovery in the 
Stable Emergency Patient  
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D.2. Subject Selection 
Subjects will be recruited in the emergency department by two trained research 
assistants (RAs).  Subjects will be recruited beginning in May 2017.  
D.2.a. Inclusion Criteria  
Patients (1) with a chief complaint of: nausea, vomiting or emesis, diarrhea, abdominal 
pain, dizziness, weakness, heat stroke or heat exhaustion, dehydration, fatigue, or 
volume depletion; (2) are deemed by their ED provider to be clinically able to receive two 
liters of fluid; (3) are being administered fluids by their ED treatment team; and (4) are 
decided to be likely to be discharged from the ED are eligible for the study.  
D.2.a. Exclusion Criteria  
Patients without consistent access to a phone with text-messaging capabilities for the 
following seven days and/or without a primary care physician will be excluded from this 
study.  Patients from the following groups will be excluded: pregnant, prisoners, did not 
speak English, were undergoing current chemotherapy, signs of jaundice, already 
received greater than 250 mL of IV fluids, or unable to provide informed consent. 
D.2.b. Subject Recruitment Plans, Screening and Consent 
Screening will begin as the patient checks in to the ED with the triage nurse and enters a 
chief complaint.  Two RAs will monitor the emergency department electronic patient list 
in real time to identify patients with eligible chief complaints.  The RA will approach the 
patient’s provider to determine if patient meets inclusion criteria (2-4).  If the provider 
determines the patient meets both inclusion criteria, the RA will approach the patient in 
his/her ED patient room to screen the patient for eligibility based on stated inclusion and 
exclusion criteria.  
 
If patient meets all inclusion criteria and does not meet any exclusion criteria, the RA will 
discuss the study with the patient using a standard, IRB-approved script.  If the patient is 
agreeable to participation in the study, written consent will be obtained and proof of 
research participation will be documented in the patient’s electronic medical record.  
D.2.c. Randomization Method and Blinding 
Randomization of intervention will be 1:1 in randomized, permuted blocks. 
Randomization will be performed in SAS (SAS Institute), version 9.4.  Blinded allocation 
(“Drug 1” or “Drug 2”) will be placed in sealed opaque envelopes labelled by subject ID 
before the enrollment period begins.  All research team members involved in patient 
enrollment and outcome assessment (survey administration) will not be involved in this 
randomization process.  
D.3. Intervention  
Following randomization, a RA will work with the nursing staff to procure the correct IV 
solution and administer the solution.  Times of initiation and termination of fluid 
administration and amount of actual fluid administered will be recorded for covariate 
analysis.  


PROTOCOL: Comparison of Lactated Ringer’s and Normal Saline IV Fluids for Quality of Recovery in the 
Stable Emergency Patient  
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D.3.a. Description  
Both intervention and control medications will be delivered intravenously via peripheral 
venous access at room-temperature.  Fluid administration rate will be 1,000 mL/15 
minutes by pressure bag method and will be monitored by an RA.  
 
Intervention is 2,000 mL lactated ringer’s IV solution (see description below).  
“Each 100 mL of Lactated Ringer’s Injection, USP contains sodium chloride 600 
mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium 
chloride, dihydrate 20 mg…  A liter provides 9 calories (from lactate), sodium 
(Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 
109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is 
isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 
mOsmol/liter). The pH of the solution is 6.6 (6.0 to 7.5).”17 
Control is 2,000 mL of normal saline (0.9% sodium chloride). 
D.3.b. Subject Compliance Monitoring  
RAs will record time of initiation and completion of each bag of IV fluid and confirm 
patient is receiving correct fluid for allocation group.  Any crossovers or premature 
stopping of fluid administration will be documented.  Actual amount of fluid (mL) received 
will be documented. 
D.3.c. Data Collection Procedures for Adverse Events 
Any adverse event occurring in the ED would be recorded by the RA. Subjects will also 
be given contact information for a study physician, trained in emergency medicine, and 
will be instructed to call with concerns or to report any adverse events. 
 
Further, an EM physician, not affiliated with the study, will be presented group data 
(blinded to treatment allocation) of 28-day patient medical treatment at the enrolling 
medical facility to assess safety for stopping.  This chart review data will be collected by 
a research team member, blinded to subject group.  Subject group (“A” or “B”) will be 
added by study statistician (treatment [“LR” or “NS”] will not be revealed).  
D.4. Study Outcome Measurements and Ascertainment 
Outcomes will be recorded by trained RAs at time of ascertainment.  RA obtaining 
outcome measurement will be blinded to subject allocation.  Data will be entered and 
stored electronically on a secure server that can be accessed from any location at the 
enrolling site.  Paper surveys will be saved in a locked file cabinet at the enrolling site.  
 
At the time of enrollment, baseline characteristics of subjects will be collected by RAs by 
in-person interview (pre-intervention QoR-40 score) and from electronic medical record 
(age, gender).  Some baseline characters will be collected at the chart abstraction (ED 
encounter disposition [discharged from ED/admitted to hospital/admitted to ICU], ED 
diagnosis type [by organ system]).  
 
D.4.a. Primary Endpoint 
The primary outcome of this study will be the post-treatment survey score of the Quality 
of Recovery-40 (QoR-40, see Attachment H-2) validated survey tool18,19.  The survey 
has been used extensively in the surgery anesthesia literature to measure patient-


PROTOCOL: Comparison of Lactated Ringer’s and Normal Saline IV Fluids for Quality of Recovery in the 
Stable Emergency Patient  
______________________________________________________________________________________ 
 
 
6 
 
 
 
reported recovery across five independent domains: Comfort, Emotion, Physical 
Independence, Patient Support, and Pain.  Survey scores range from 40 to 200.  
 
RAs will administer the QoR-40 to subjects initially before any intervention is 
administered (“pre”).  Twenty-four hours following discharge, the RAs will administer the 
survey again by telephone (“post”).  During survey administration, RA will fill-out survey 
on paper, and it will later be entered into the electronic database.  If patient does not 
answer, two additional phone calls will be made in the 24-48 hours following ED 
discharge.  Time of “post” survey response will be recorded. 
 
D.4.b. Secondary Endpoint 
Secondary endpoints are designed to examine differences in healthcare administration 
between the NS control and LR intervention groups.  Secondary endpoints will be 
assessed at two time points (1) at the 24-hour post-discharge phone call and (2) with a 
7-day follow-up text message utilizing a two-way text messaging system. 
 
The following secondary endpoints will be recorded:  
(A)  Sought additional healthcare for same complaint, 
(B)  Returned to an ED for same complaint, 
(C) Filled an ED prescription from visit of enrollment, and 
Each endpoint will be a dichotomous (yes/no) response.  No adjudication of “same 
complaint” will be performed by the research team, as the intention is to capture the 
patient’s interpretation of healthcare utilization from the illness. 
 
D.4.c. Subgroups 
No a priori subgroup analyses are planned.  Any subgroup analyses performed will be 
solely for the purpose of hypothesis generation. 
E. Statistical Plan  
E.1.  Sample Size Determination and Power 
Sample size calculation was based on the detection of a 10-point difference on the QoR-
40 survey scores.  A 10-pt difference was selected as the minimum detectable difference 
maintaining clinical relevance, as supported by previous studies18-21. Sample size 
calculation (α = 0.05, β = 0.90, 20% dropout, difference of 10 points) revealed a need for 
156 total subjects.  
E.2.  Statistical Analysis 
Baseline characteristics. Baseline characteristics will be reported with summary statistics 
as appropriate (mean, SD, median, IQR) and differences in characteristics will be 
conducted using t-test for continuous variables and chi-square test for categorical 
variables.  If any baseline characteristics have significant differences, those behaviors 
will be reported in the results section and an adjusted analysis will be performed on 
primary and secondary variables to assess the impact of the imbalances. 
 
Primary outcome. The primary outcome, pre-post difference in 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.  Due to the nature of emergency department 


PROTOCOL: Comparison of Lactated Ringer’s and Normal Saline IV Fluids for Quality of Recovery in the 
Stable Emergency Patient  
______________________________________________________________________________________ 
 
 
7 
 
 
 
research, an additional analysis will be done by treatment received and compared to the 
primary ITT analysis. 
 
Secondary outcome & safety analysis. Secondary outcomes will be reported as a 
relative risk with 95%CI in an ITT analysis.  A safety analysis of selected secondary 
outcomes (return to ED and seeking additional healthcare for same complaint) will be 
performed by treatment received.  
 
Covariate analysis. Differences in actual fluid administered and time from intervention to 
primary outcome will be assessed.  If significant, analysis adjusting for covariates of time 
from intervention to primary outcome, post-QoR-40 administration, and amount of fluid 
(mL) received will performed with multivariable linear regression and multivariable 
logistic regression (primary and secondary outcomes, respectively).  
 
F. Quality Control  
F.1. Study Monitoring Plan  
Study accrual will be reported weekly by RAs.  Study accrual is expected to be about 13 
subjects per week.  Full research team meetings will occur if study accrual falls below 
80% of expected total accrual for any end-of-the-week accrual reports.  The purpose of 
the meeting will be develop and implement strategies to increase subject accrual. 
Potential solutions could include utilization of trained ED enrollers currently in the 
department, additional training and education of ED medical and nursing staff on the 
study, and recommendations to RAs by current clinicians on increasing visibility and 
awareness of the study during ED clinical shifts.  Concerns will be addressed in a weekly 
meeting of RAs and investigators at enrollment site.  
 
Safety reporting will occur after enrollment of every 30 subjects (the last group will be 36 
subjects).  If an adverse event is recorded, the Safety Coordinator will review the event 
within 24 hours. The local IRB will also be notified. 
F.2. Data Review 
Data from paper surveys and enrollment forms will be entered into a secure database by 
the RAs.  At the end of enrollment and before analysis, one investigator will perform a 
10% audit of the data.  Concordance will be measured using a κ statistic.  Following 
audit, the database will be locked for analysis.  
G. Study Administration 
G.1. Organization and Participating Centers 
Enrollment for this single center study will occur at: 
  
Emergency Treatment Center  
Department of Emergency Medicine  
University of Iowa Hospitals and Clinics 
200 Hawkins Dr. 
Iowa City, IA 52242 


PROTOCOL: Comparison of Lactated Ringer’s and Normal Saline IV Fluids for Quality of Recovery in the 
Stable Emergency Patient  
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Investigators, study statistician, research assistants, and safety coordinator are affiliated 
with the University of Iowa.  
 
H.  Attachments  
H.1.  Procedure Table  
 
 
Timeline 
 Measure 
Baseline (Before 
Intervention) 
During 
Intervention 
Phone call: 24 
hours after 
ED discharge 
Text message:  
7 days after ED 
discharge 
Chart review: 
28 days after ED 
discharge 
Quality of Recovery-40 
X 
 
X  
 
 
Time and Amount of 
Fluid Administered 
 
X 
 
 
 
Returned to ED for 
same complaint 
 
 
X 
X 
 
Sought additional 
healthcare for same 
complaint 
 
 
X 
X 
 
Filled ED prescription 
 
 
X 
X 
 
Adverse Event 
Monitoring 
 
X 
X 
X 
X 
 
 
 
 
 


PROTOCOL: Comparison of Lactated Ringer’s and Normal Saline IV Fluids for Quality of Recovery in the 
Stable Emergency Patient  
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H.2. Primary Outcome Survey, “Quality of Recovery-40”18 
 
 


PROTOCOL: Comparison of Lactated Ringer’s and Normal Saline IV Fluids for Quality of Recovery in the 
Stable Emergency Patient  
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blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-
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16. Payment Allowance Limits for Medicare Part B Drugs. 2016.  
17. lactated ringer's (Sodium chloride, sodium lactate, potassium chloride, and calcium 
chloride)  injection, solution. 2007.  
18. Myles PS, Hunt JO, Nightingale CE, et al. Development and psychometric testing of 
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19. Gornall BF, Myles PS, Smith CL, et al. Measurement of quality of recovery using the 
QoR-40: a quantitative systematic review. Br J Anaesth 2013;111:161-9. 


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Stable Emergency Patient  
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20. Asakura A, Mihara T, Goto T. The Effect of Preoperative Oral Carbohydrate or Oral 
Rehydration Solution on Postoperative Quality of Recovery: A Randomized, 
Controlled Clinical Trial. PLoS One 2015;10:e0133309. 
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with desflurane anaesthesia. Br J Anaesth 2015;114:663-8.