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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02614040
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Wesley Self, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Critical Illness Acute Kidney Injury Other: 0.9% Saline Other: Physiologically-balanced isotonic crystalloid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SaLt-ED)
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017


Arm Intervention/treatment
Active Comparator: 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.
Other: 0.9% Saline
0.9% Saline will be used whenever an isotonic crystalloid is ordered
Other Names:
  • Normal saline
  • 0.9% sodium chloride

Active Comparator: 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.
Other: Physiologically-balanced isotonic crystalloid
Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered
Other Names:
  • Lactated Ringers
  • Ringer's Lactate
  • Plasma-Lyte© A




Primary Outcome Measures :
  1. Hospital-free days to day 28 [ Time Frame: 28 days after enrollment ]
    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 :
  1. Stage II or greater KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES (KDIGO) Acute Kidney Injury [ Time Frame: 30 days after enrollment censored at hospital discharge ]
    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).

  2. Major adverse kidney event by hospital discharge or day 30 (MAKE30) [ Time Frame: 30 days after enrollment ]
    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.

  3. In-Hospital Mortality [ Time Frame: 30 days or hospital discharge, whichever occurs first ]
    Death before hospital discharge

  4. Hospital length of stay [ Time Frame: Hospital length of stay assessed 90 days after enrollment ]
    Duration of hospitalization

  5. ICU-free days to day 28 [ Time Frame: 28 days ]
    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.

  6. Ventilator-free days to day 28 [ Time Frame: 28 days ]
    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.

  7. Vasopressor-free days [ Time Frame: 28 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.

  8. Receipt of new renal replacement therapy [ Time Frame: 30 days after enrollment or hospital discharge, whichever occurs first ]
    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

  9. Duration of new renal replacement therapy [ Time Frame: 30 days after enrollment ]
    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

  10. Peak creatinine [ Time Frame: 28 days after enrollment or hospital discharge, whichever occurs first ]
    Highest creatinine in the 28 days after enrollment or hospital discharge, whichever occurs first

  11. Change from baseline to peak creatinine [ Time Frame: 28 days after enrollment or hospital discharge, whichever occurs first ]
    Change from baseline creatinine at enrollment to the highest creatinine before death or hospital discharge in the first 28 days

  12. Incidence of metabolic acidosis and alkalosis [ Time Frame: 30 days after enrollment or hospital discharge, whichever occurs first ]
    Incidence of metabolic acidosis and alkalosis in the first 30 days after enrollment as defined by bicarbonate values outside of the laboratory normal range.

  13. Incidence of hyperchloremia and hypochloremia [ Time Frame: 30 days after enrollment or hospital discharge, whichever occurs first ]
    Incidence of hyperchloremia and hypochloremia in the first 30 days after enrollment as defined by serum chloride values outside of the laboratory normal range.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614040


Locations
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United States, Tennessee
Vanderbilt University Medical Center Adult Emergency Department
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Wesley Self, MD MPH Vanderbilt University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wesley Self, Associate Professor of Emergency Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02614040    
Other Study ID Numbers: 151769
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Keywords provided by Wesley Self, Vanderbilt University:
crystalloid
acute kidney injury
Additional relevant MeSH terms:
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Acute Kidney Injury
Emergencies
Critical Illness
Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions