Saline Against Lactated Ringers or Plasmalyte in the Emergency Department

Critical Illness Clinical Trial

— SaLt-ED  

Official title:

Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SaLt-ED)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614040
• Other study ID #: 151769
• Status: Completed
• Phase: N/A
• First received: November 18, 2015
• Last updated: September 14, 2017
• Start date: January 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: September 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14000
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Emergencies

Intervention

Other:
• 0.9% Saline
0.9% Saline will be used whenever an isotonic crystalloid is ordered
• Physiologically-balanced isotonic crystalloid
Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center Adult Emergency Department	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Erratum in: JAMA. 2015 Dec 15;314(23):2570. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stage II or greater KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES (KDIGO) Acute Kidney Injury	Proportion of patients with Stage II or greater acute kidney injury by KDIGO creatinine criteria (defined as rise in serum creatinine level of at least 2-fold, a serum creatinine level greater than or equal to 4.0 mg/dL with an acute increase of at least 0.5 mg/dL, or initiation of new renal replacement therapy).	30 days after enrollment censored at hospital discharge
Secondary	Major adverse kidney event by hospital discharge or day 30 (MAKE30)	At least one of: death, new renal replacement therapy, or persistent renal dysfunction at the time of hospital discharge (serum creatinine level = 200% of baseline). Patients discharged prior to day 30 will be assumed not to develop this outcome between hospital discharge and day 30.	30 days after enrollment
Secondary	In-Hospital Mortality	Death before hospital discharge	30 days or hospital discharge, whichever occurs first
Secondary	Hospital length of stay	Duration of hospitalization	Hospital length of stay assessed 90 days after enrollment
Secondary	ICU-free days to day 28	Days alive and free of the intensive care unit in the first 28 days. Patients discharged prior to day 28 will be assumed to not have ICU days between discharge and day 28.	28 days
Secondary	Ventilator-free days to day 28	Days alive and free of mechanical ventilation in the first 28 days. Patients discharged prior to day 28 will be assumed to not have any ventilator days between discharge and day 28.	28 days
Secondary	Vasopressor-free days	Days alive and free of vasopressor receipt in the first 28 days. Patients discharged prior to day 28 will be assumed to not have vasopressor days between discharge and day 28.	28 days
Secondary	Receipt of new renal replacement therapy	Receipt of any form of renal replacement therapy in the first 30 days after enrollment in a patient who had not received renal replacement therapy prior to enrollment	30 days after enrollment or hospital discharge, whichever occurs first
Secondary	Duration of new renal replacement therapy	Duration of renal replacement therapy in the first 30 days after enrollment in a patient who had not received renal replacement therapy prior to enrollment	30 days after enrollment
Secondary	Peak creatinine	Highest creatinine in the 28 days after enrollment or hospital discharge, whichever occurs first	28 days after enrollment or hospital discharge, whichever occurs first
Secondary	Change from baseline to peak creatinine	Change from baseline creatinine at enrollment to the highest creatinine before death or hospital discharge in the first 28 days	28 days after enrollment or hospital discharge, whichever occurs first
Secondary	Incidence of metabolic acidosis and alkalosis	Incidence of metabolic acidosis and alkalosis in the first 30 days after enrollment as defined by bicarbonate values outside of the laboratory normal range.	30 days after enrollment or hospital discharge, whichever occurs first
Secondary	Incidence of hyperchloremia and hypochloremia	Incidence of hyperchloremia and hypochloremia in the first 30 days after enrollment as defined by serum chloride values outside of the laboratory normal range.	30 days after enrollment or hospital discharge, whichever occurs first