NCT02614040

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

1.5 years

First QC Date

November 18, 2015

Last Update Submit

September 14, 2017

Conditions

Critical IllnessAcute Kidney Injury

Keywords

crystalloidacute kidney injury

Outcome Measures

Primary Outcomes (1)

  • Hospital-free days to day 28

    The number of days alive and free of hospitalization in the first 28 days after study enrollment. Patients alive at the time of discharge will be presumed to be alive at 28 days. A patient who dies before hospital discharge will receive zero hospital-free days. A patient who remains in the hospital 28 days after enrollment will receive zero hospital-free days.

    28 days after enrollment

Secondary Outcomes (13)

  • Stage II or greater KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES (KDIGO) Acute Kidney Injury

    30 days after enrollment censored at hospital discharge

  • Major adverse kidney event by hospital discharge or day 30 (MAKE30)

    30 days after enrollment

  • In-Hospital Mortality

    30 days or hospital discharge, whichever occurs first

  • Hospital length of stay

    Hospital length of stay assessed 90 days after enrollment

  • ICU-free days to day 28

    28 days

  • +8 more secondary outcomes

Study Arms (2)

0.9% Saline

ACTIVE COMPARATOR

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.

Other: 0.9% Saline

Physiologically-balanced

ACTIVE COMPARATOR

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.

Other: Physiologically-balanced isotonic crystalloid

Interventions

0.9% SalineOTHER

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

Also known as: Normal saline, 0.9% sodium chloride
0.9% Saline
Physiologically-balanced isotonic crystalloidOTHER

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

Also known as: Lactated Ringers, Ringer's Lactate, Plasma-Lyte© A
Physiologically-balanced

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient in the Vanderbilt Adult Emergency Department
  • Felt by treating clinician to require intravenous isotonic crystalloid
  • Felt by treating clinician to require inpatient hospital admission

You may not qualify if:

  • \. Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center Adult Emergency Department

Nashville, Tennessee, 37232, United States

Location

Related Publications (6)

  • 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.

    PMID: 20950434BACKGROUND

  • 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.

    PMID: 23073953BACKGROUND

  • 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.

    PMID: 26444692BACKGROUND

  • 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.

    PMID: 33196806DERIVED

  • 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.

    PMID: 29485926DERIVED

  • 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.

    PMID: 28407811DERIVED

MeSH Terms

Conditions

Critical IllnessAcute Kidney Injury

Interventions

Saline SolutionSodium ChlorideRinger's Lactate

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Wesley Self, MD MPH

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Emergency Medicine

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 25, 2015

Study Start

January 1, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations

US(1)