Acute Kidney Injury, Critical Illness
Conditions
Keywords
crystalloid, acute kidney injury
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.
Interventions
OTHER0.9% Saline
0.9% Saline will be used whenever an isotonic crystalloid is ordered
Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital-free days to day 28 | 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
| Measure | Time frame | Description |
|---|---|---|
| Major adverse kidney event by hospital discharge or day 30 (MAKE30) | 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. |
| In-Hospital Mortality | 30 days or hospital discharge, whichever occurs first | Death before hospital discharge |
| Hospital length of stay | Hospital length of stay assessed 90 days after enrollment | Duration of hospitalization |
| ICU-free days to day 28 | 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. |
| Ventilator-free days to day 28 | 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. |
| Vasopressor-free days | 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. |
| Stage II or greater KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES (KDIGO) Acute Kidney Injury | 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). |
| Duration of new renal replacement therapy | 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 |
| Peak creatinine | 28 days after enrollment or hospital discharge, whichever occurs first | Highest creatinine in the 28 days after enrollment or hospital discharge, whichever occurs first |
| Change from baseline to peak creatinine | 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 |
| Incidence of metabolic acidosis and alkalosis | 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. |
| Incidence of hyperchloremia and hypochloremia | 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. |
| Receipt of new renal replacement therapy | 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 |
Countries
United States
Outcome results
None listed