Clinical trial NCT02614040: Saline Against Lactated Ringers or Plasmalyte in the Emergency Department
Official title: Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SaLt-ED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Acute Kidney Injury
Keywords: crystalloid
acute kidney injury
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 14000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital-free days to day 28
timeFrame: 28 days after enrollment
Secondary outcomes:
measure: Stage II or greater KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES (KDIGO) Acute Kidney Injury
timeFrame: 30 days after enrollment censored at hospital discharge
measure: Major adverse kidney event by hospital discharge or day 30 (MAKE30)
timeFrame: 30 days after enrollment
measure: In-Hospital Mortality
timeFrame: 30 days or hospital discharge, whichever occurs first
measure: Hospital length of stay
timeFrame: Hospital length of stay assessed 90 days after enrollment
measure: ICU-free days to day 28
timeFrame: 28 days
measure: Ventilator-free days to day 28
timeFrame: 28 days
measure: Vasopressor-free days
timeFrame: 28 days
measure: Receipt of new renal replacement therapy
timeFrame: 30 days after enrollment or hospital discharge, whichever occurs first
measure: Duration of new renal replacement therapy
timeFrame: 30 days after enrollment
measure: Peak creatinine
timeFrame: 28 days after enrollment or hospital discharge, whichever occurs first
measure: Change from baseline to peak creatinine
timeFrame: 28 days after enrollment or hospital discharge, whichever occurs first
measure: Incidence of metabolic acidosis and alkalosis
timeFrame: 30 days after enrollment or hospital discharge, whichever occurs first
measure: Incidence of hyperchloremia and hypochloremia
timeFrame: 30 days after enrollment or hospital discharge, whichever occurs first
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Adult Emergency Department
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Wesley Self, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.