Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation

NCT03133767 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 201701764
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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 Surveys show physicians do not cite an evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to be influenced by type and location of practice.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

Conditions

Fluid Loss; Symptom Complex, Triple; Emergencies

Keywords

Normal saline; Lactated ringers; Emergency department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of Recovery-40 Score After Administration

  Immediately after fluid administration

• Number of Participants That Filled an ED Prescription

  7 days after study enrollment

• Number of Participants That Returned to the ED Within 7 Days for the Same Complaint

  7 days

• Participants That Sought Care From Another Healthcare Provider for the Same Complaint

  7 days

Study Arms (2)

Lactated ringers solution

EXPERIMENTAL

Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay

Drug: Lactated Ringer Solution

Normal saline solution

EXPERIMENTAL

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

Interventions

Lactated Ringer Solution DRUG

2 liters of intravenous lactated ringers solution will be administered by peripheral IV

Lactated ringers solution

Normal Saline 0.9% Infusion Solution Bag DRUG

2 liters of intravenous normal saline solution will be administered by peripheral IV

Normal saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prisoners
• Children
• Women known to be pregnant
• Jaundice
• Current chemotherapy

Sponsors & Collaborators

• Nicholas M Mohr: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• Friederich A, Martin N, Swanson MB, Faine BA, Mohr NM. Normal Saline Solution and Lactated Ringer's Solution Have a Similar Effect on Quality of Recovery: A Randomized Controlled Trial. Ann Emerg Med. 2019 Feb;73(2):160-169. doi: 10.1016/j.annemergmed.2018.07.007. Epub 2018 Aug 23.

  PMID: 30146446 DERIVED

MeSH Terms

Conditions

Behcet Syndrome; Emergencies

Interventions

Ringer's Lactate; Saline Solution

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Nicholas Mohr
• Organization: University of Iowa

nicholas-mohr@uiowa.edu

319-384-8285

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: April 28, 2017
• Study Start: May 23, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 2, 2017
• Last Updated: September 11, 2018
• Results First Posted: September 11, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)