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Completed

NCT Number: NCT02614040

Saline Against Lactated Ringers or Plasmalyte in the Emergency Department

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center Adult Emergency Department

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Age < 18 years

Treatment and study plan

0.9% saline

Other

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

Other names: Normal saline, 0.9% sodium chloride

Physiologically-balanced isotonic crystalloid

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Acronym: SaLt-ED

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 25, 2015
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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