Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SaLt-ED)
Primary Purpose
Critical Illness, Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
0.9% Saline
Physiologically-balanced isotonic crystalloid
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring crystalloid, acute kidney injury
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
1. Age < 18 years
Sites / Locations
- Vanderbilt University Medical Center Adult Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
0.9% Saline
Physiologically-balanced
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
In-Hospital Mortality
Death before hospital discharge
Hospital length of stay
Duration of hospitalization
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.
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.
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.
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
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
Peak creatinine
Highest creatinine in the 28 days after enrollment or hospital discharge, whichever occurs first
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
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.
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.
Full Information
NCT ID
NCT02614040
First Posted
November 18, 2015
Last Updated
September 14, 2017
Sponsor
Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT02614040
Brief Title
Saline Against Lactated Ringers or Plasmalyte in the Emergency Department
Acronym
SaLt-ED
Official Title
Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SaLt-ED)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Acute Kidney Injury
Keywords
crystalloid, acute kidney injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.9% Saline
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Physiologically-balanced
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
0.9% Saline
Other Intervention Name(s)
Normal saline, 0.9% sodium chloride
Intervention Description
0.9% Saline will be used whenever an isotonic crystalloid is ordered
Intervention Type
Other
Intervention Name(s)
Physiologically-balanced isotonic crystalloid
Other Intervention Name(s)
Lactated Ringers, Ringer's Lactate, Plasma-Lyte© A
Intervention Description
Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered
Primary Outcome Measure Information:
Title
Hospital-free days to day 28
Description
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.
Time Frame
28 days after enrollment
Secondary Outcome Measure Information:
Title
Stage II or greater KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES (KDIGO) Acute Kidney Injury
Description
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).
Time Frame
30 days after enrollment censored at hospital discharge
Title
Major adverse kidney event by hospital discharge or day 30 (MAKE30)
Description
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.
Time Frame
30 days after enrollment
Title
In-Hospital Mortality
Description
Death before hospital discharge
Time Frame
30 days or hospital discharge, whichever occurs first
Title
Hospital length of stay
Description
Duration of hospitalization
Time Frame
Hospital length of stay assessed 90 days after enrollment
Title
ICU-free days to day 28
Description
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.
Time Frame
28 days
Title
Ventilator-free days to day 28
Description
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.
Time Frame
28 days
Title
Vasopressor-free days
Description
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.
Time Frame
28 days
Title
Receipt of new renal replacement therapy
Description
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
Time Frame
30 days after enrollment or hospital discharge, whichever occurs first
Title
Duration of new renal replacement therapy
Description
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
Time Frame
30 days after enrollment
Title
Peak creatinine
Description
Highest creatinine in the 28 days after enrollment or hospital discharge, whichever occurs first
Time Frame
28 days after enrollment or hospital discharge, whichever occurs first
Title
Change from baseline to peak creatinine
Description
Change from baseline creatinine at enrollment to the highest creatinine before death or hospital discharge in the first 28 days
Time Frame
28 days after enrollment or hospital discharge, whichever occurs first
Title
Incidence of metabolic acidosis and alkalosis
Description
Incidence of metabolic acidosis and alkalosis in the first 30 days after enrollment as defined by bicarbonate values outside of the laboratory normal range.
Time Frame
30 days after enrollment or hospital discharge, whichever occurs first
Title
Incidence of hyperchloremia and hypochloremia
Description
Incidence of hyperchloremia and hypochloremia in the first 30 days after enrollment as defined by serum chloride values outside of the laboratory normal range.
Time Frame
30 days after enrollment or hospital discharge, whichever occurs first
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
1. Age < 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley Self, MD MPH
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center Adult Emergency Department
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20950434
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.
Results Reference
background
PubMed Identifier
23073953
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.
Results Reference
background
PubMed Identifier
26444692
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.
Results Reference
background
PubMed Identifier
33196806
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.
Results Reference
derived
PubMed Identifier
29485926
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.
Results Reference
derived
PubMed Identifier
28407811
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.
Results Reference
derived
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Saline Against Lactated Ringers or Plasmalyte in the Emergency Department
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