An interventional study of 0.9% Saline and Physiologically-balanced isotonic crystalloid in Critical Illness and Acute Kidney Injury, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-15.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment
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.
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.
1,594 studies on the registry are indexed under Acute Kidney Injury; 370 are open to participants now.
This study's enrollment of 14,000 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
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Exclusion Criteria:
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
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
0.9% Saline will be used whenever an isotonic crystalloid is ordered
Also known as: Normal saline, 0.9% sodium chloride
Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered
Also known as: Lactated Ringers, Ringer's Lactate, Plasma-Lyte© A
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.
Time frame: 28 days after enrollment
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).
Time frame: 30 days after enrollment censored at hospital discharge
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.
Time frame: 30 days after enrollment
In-Hospital Mortality
Death before hospital discharge
Time frame: 30 days or hospital discharge, whichever occurs first
Hospital length of stay
Duration of hospitalization
Time frame: Hospital length of stay assessed 90 days after enrollment
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.
Time frame: 28 days
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.
Time frame: 28 days
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.
Time frame: 28 days
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
Time frame: 30 days after enrollment or hospital discharge, whichever occurs first
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
Time frame: 30 days after enrollment
Peak creatinine
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
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
Time frame: 28 days after enrollment or hospital discharge, whichever occurs first
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.
Time frame: 30 days after enrollment or hospital discharge, whichever occurs first
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.
Time frame: 30 days after enrollment or hospital discharge, whichever occurs first
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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