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Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation

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ClinicalTrials.gov Identifier: NCT03133767
Recruitment Status : Completed
First Posted : April 28, 2017
Results First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Nicholas M Mohr, University of Iowa

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 Surveys show physicians do not cite an evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to be influenced by type and location of practice.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


Condition or disease Intervention/treatment Phase
Fluid Loss Symptom Complex, Triple Emergencies Drug: Lactated Ringer Solution Drug: Normal Saline 0.9% Infusion Solution Bag Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Fluid being administered to participants will be covered by an opaque bag. The investigator calling the participant for follow-up does not know how the participant was allocated.
Primary Purpose: Treatment
Official Title: Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 2, 2017


Arm Intervention/treatment
Experimental: Lactated ringers solution
Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay
Drug: Lactated Ringer Solution
2 liters of intravenous lactated ringers solution will be administered by peripheral IV

Experimental: Normal saline solution
Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay
Drug: Normal Saline 0.9% Infusion Solution Bag
2 liters of intravenous normal saline solution will be administered by peripheral IV




Primary Outcome Measures :
  1. Quality of Recovery-40 Score at 24 Hours [ Time Frame: 24 hours after ED visit ]
    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.


Secondary Outcome Measures :
  1. Quality of Recovery-40 Score After Administration [ Time Frame: Immediately after fluid 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.

  2. Number of Participants That Filled an ED Prescription [ Time Frame: 7 days after study enrollment ]
    Seven days after study enrollment, participants were asked by text message, "Have you filled any prescriptions from the emergency department?"

  3. Number of Participants That Returned to the ED Within 7 Days for the Same Complaint [ Time Frame: 7 days ]
    Seven days after study enrollment, participants were asked by text message, "Have you returned to the emergency department for the same problem?"

  4. Participants That Sought Care From Another Healthcare Provider for the Same Complaint [ Time Frame: 7 days ]
    Seven days after study enrollment, participants were asked by text message, "Have you seen another medical provider for the same complaint?".



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133767


Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Nicholas M Mohr
  Study Documents (Full-Text)

Documents provided by Nicholas M Mohr, University of Iowa:

Responsible Party: Nicholas M Mohr, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03133767     History of Changes
Other Study ID Numbers: 201701764
First Posted: April 28, 2017    Key Record Dates
Results First Posted: September 11, 2018
Last Update Posted: September 11, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Nicholas M Mohr, University of Iowa:
Normal saline
Lactated ringers
Emergency department

Additional relevant MeSH terms:
Behcet Syndrome
Emergencies
Disease Attributes
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Pharmaceutical Solutions