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Saline Against Lactated Ringers or Plasmalyte in the Emergency Department

NCT ID: NCT02614040

Last Updated: 2017-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-06-30

Brief Summary

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This study will be a cluster-randomized, single-center trial comparing 0.9% saline (normal saline) vs physiologically-balanced crystalloid fluids (Lactated Ringers or Plasmalyte A) for intravenous fluid administration in the emergency department.

Detailed Description

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The administration of intravenous fluids is ubiquitous in the care of the acutely ill. Commonly available isotonic crystalloid solutions contain a broad spectrum of electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SaLt-ED will be a large, cluster-randomized trial enrolling adults requiring intravenous isotonic crystalloid administration and hospital admission from the Vanderbilt University Emergency Department from January 1st 2016 until April 30 2017. The primary endpoint will be hospital-free days to day 28.

Conditions

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Critical Illness Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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0.9% Saline

Patients in a month randomized to physiologically-balanced isotonic fluid will receive 0.9% Saline whenever isotonic intravenous fluid administration is ordered by the treating provider.

Group Type ACTIVE_COMPARATOR

0.9% Saline

Intervention Type OTHER

0.9% Saline will be used whenever an isotonic crystalloid is ordered

Physiologically-balanced

Patients in a month randomized to physiologically-balanced isotonic fluid will receive physiologically-balanced isotonic crystalloid (Plasma-Lyte© A or Lactated Ringer's) whenever isotonic intravenous fluid administration is ordered by the treating provider.

Group Type ACTIVE_COMPARATOR

Physiologically-balanced isotonic crystalloid

Intervention Type OTHER

Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered

Interventions

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0.9% Saline

0.9% Saline will be used whenever an isotonic crystalloid is ordered

Intervention Type OTHER

Physiologically-balanced isotonic crystalloid

Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered

Intervention Type OTHER

Other Intervention Names

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Normal saline 0.9% sodium chloride Lactated Ringers Ringer's Lactate Plasma-Lyte© A

Eligibility Criteria

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Inclusion Criteria

1. Patient in the Vanderbilt Adult Emergency Department
2. Felt by treating clinician to require intravenous isotonic crystalloid
3. Felt by treating clinician to require inpatient hospital admission

Exclusion Criteria

1\. Age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Wesley Self

Associate Professor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wesley Self, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Vanderbilt University Medical Center Adult Emergency Department

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Finfer S, Liu B, Taylor C, Bellomo R, Billot L, Cook D, Du B, McArthur C, Myburgh J; SAFE TRIPS Investigators. Resuscitation fluid use in critically ill adults: an international cross-sectional study in 391 intensive care units. Crit Care. 2010;14(5):R185. doi: 10.1186/cc9293. Epub 2010 Oct 15.

Reference Type BACKGROUND
PMID: 20950434 (View on PubMed)

Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.

Reference Type BACKGROUND
PMID: 23073953 (View on PubMed)

Young P, Bailey M, Beasley R, Henderson S, Mackle D, McArthur C, McGuinness S, Mehrtens J, Myburgh J, Psirides A, Reddy S, Bellomo R; SPLIT Investigators; ANZICS CTG. Effect of a Buffered Crystalloid Solution vs Saline on Acute Kidney Injury Among Patients in the Intensive Care Unit: The SPLIT Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1701-10. doi: 10.1001/jama.2015.12334.

Reference Type BACKGROUND
PMID: 26444692 (View on PubMed)

Self WH, Evans CS, Jenkins CA, Brown RM, Casey JD, Collins SP, Coston TD, Felbinger M, Flemmons LN, Hellervik SM, Lindsell CJ, Liu D, McCoin NS, Niswender KD, Slovis CM, Stollings JL, Wang L, Rice TW, Semler MW; Pragmatic Critical Care Research Group. Clinical Effects of Balanced Crystalloids vs Saline in Adults With Diabetic Ketoacidosis: A Subgroup Analysis of Cluster Randomized Clinical Trials. JAMA Netw Open. 2020 Nov 2;3(11):e2024596. doi: 10.1001/jamanetworkopen.2020.24596.

Reference Type DERIVED
PMID: 33196806 (View on PubMed)

Self WH, Semler MW, Wanderer JP, Wang L, Byrne DW, Collins SP, Slovis CM, Lindsell CJ, Ehrenfeld JM, Siew ED, Shaw AD, Bernard GR, Rice TW; SALT-ED Investigators. Balanced Crystalloids versus Saline in Noncritically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):819-828. doi: 10.1056/NEJMoa1711586. Epub 2018 Feb 27.

Reference Type DERIVED
PMID: 29485926 (View on PubMed)

Self WH, Semler MW, Wanderer JP, Ehrenfeld JM, Byrne DW, Wang L, Atchison L, Felbinger M, Jones ID, Russ S, Shaw AD, Bernard GR, Rice TW. Saline versus balanced crystalloids for intravenous fluid therapy in the emergency department: study protocol for a cluster-randomized, multiple-crossover trial. Trials. 2017 Apr 13;18(1):178. doi: 10.1186/s13063-017-1923-6.

Reference Type DERIVED
PMID: 28407811 (View on PubMed)

Other Identifiers

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151769

Identifier Type: -

Identifier Source: org_study_id