The administration of intravenous crystalloids is ubiquitous in the care of the critically ill. Commonly available crystalloid solutions contain a broad spectrum of electrolyte compositions including a range of chloride concentrations. Recent studies of associated higher fluid chloride content with acute kidney injury and mortality but no large, randomized trials have been conducted. In preparation for a large, cluster-randomized, multiple-crossover trial comparing 0.9% sodium chloride to physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasmalyte-A) in intensive care unit patients, this pilot study will enroll all patients admitted to the medical intensive care unit at a single tertiary center for a sixth month period. The primary objective will be to test the ability of an electronic order entry tool to ensure administration of assigned study fluid or record contraindications to assigned study fluid. The pilot study will also demonstrate the feasibility of collecting demographic, severity of illness, fluid management, vital sign, laboratory, acute kidney injury and renal replacement therapy, and outcome data in an automated, electronic fashion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
974
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Proportion of Isotonic Crystalloid Which is 0.9% Saline
Proportion of total intravenous isotonic crystalloid administered during admission to the intensive care unit that is 0.9% sodium chloride, censored at 30 days. The primary outcome was the proportion of intravenous isotonic crystalloid administered in the ICU that was saline. This was a continuous variable calculated for each patient as the volume of saline received divided by volume of saline received plus volume of balanced crystalloids received with a range from 0.0 (no saline received) to 1.0 (only saline received).
Time frame: 30 days
Proportion of Isotonic Crystalloid Which is Physiologically Balanced
Proportion of total intravenous isotonic crystalloid administered during admission to the intensive care unit that is either Lactated ringers or Plasmalyte-A, censored at 30 days.
Time frame: 30 days
Total Intravenous Input
Total volume of intravenous fluid administration during admission to the intensive care unit, censored at 30 days
Time frame: 30 days
Total Isotonic Crystalloid Input
Total volume of intravenous isotonic crystalloid administration during admission to the intensive care unit, censored at 30 days
Time frame: 30 days
Total Intravenous Colloid Input
Total volume of intravenous colloid administration (excluding blood products) during admission to the intensive care unit, censored at 30 days
Time frame: 30 days
Total Intravenous Blood Product Administration
Total volume of packed red blood cells, platelets, and fresh frozen plasma administered during admission to the intensive care unit, censored at 30 days
Time frame: 30 days
Highest Serum Chloride Between Enrollment and Day 30
highest serum chloride (mmol/L) during admission to the intensive care unit, censored at 30 days
Time frame: 30 days
Highest Serum Sodium Between Enrollment and Day 30
Highest serum sodium concentration (mmol/L) during admission to the intensive care unit, censored at 30 days
Time frame: 30 days
Lowest Bicarbonate Concentration Between Enrollment and Day 30
Lowest serum bicarbonate concentration (mmol/L) during admission to the intensive care unit, censored at 30 days
Time frame: 30 days
Number of Patients With MAKE30
Incidence of Major Adverse Kidney Events by 30 days -- a composite outcome defined as one or more of the following: death, new use of renal replacement therapy, or persistence of renal dysfunction at hospital discharge or at 30 days (defined as an increase in serum creatinine ≥ 200% from baseline)
Time frame: 30 days
In-hospital Mortality
Death prior to the earlier of hospital discharge or day 30
Time frame: 30 days
New Use of Renal Replacement Therapy
Receipt of new renal replacement therapy after the first study day, censored at 30 days
Time frame: 30 days
Persistent Renal Dysfunction
Persistence of renal dysfunction at hospital discharge or at 30 days (defined as an increase in serum creatinine ≥ 200% from baseline)
Time frame: 30 days
Number of Contraindications
Number of contraindications to assigned study fluid identified by providers, censored at 30 days
Time frame: 30 days
Incidence of Hyperchloremia
Incidence of hyperchloremia defined as a serum chloride greater than or equal to 110 mmol/L
Time frame: 30 days
Incidence of Severe Hypochloremia
Incidence of severe hypochloremia defined as a serum chloride less than 90mmol/L
Time frame: 30 days
Increase in Serum Creatinine
Increase in serum creatinine during hospitalization, censored at 30 days Change from baseline to highest value, median (IQR), mg/dl
Time frame: 30 days
Incidence of Acute Kidney Injury
Incidence of stage II or III acute kidney injury by Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury criteria, censored at 30 days
Time frame: 30 days
Intensive Care Unit Free Days to Day 28
ICU-free days to 28 days after enrollment will be defined as the number of days alive and not admitted to an intensive care unit service after the patient's final discharge from the intensive care unit before 28 days. If the patient is admitted to an intensive care unit service at day 28 or dies prior to day 28, ICU-free days will be 0.
Time frame: 28 days
Ventilator-free Days (VFD) to Day 28
Ventilator-free days to day 28 will be defined as the number of days alive and with unassisted breathing to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing. If a patient returns to assisted breathing and subsequently achieves unassisted breathing prior to day 28, VFD will be counted from the end of the last period of assisted breathing to day 28. If the patient is receiving assisted ventilation at day 28 or dies prior to day 28, VFD will be 0.
Time frame: 28 days
Dialysis-free Survival to Day 28
Dialysis free survival to day 28 will be defined as the number of days alive and without dialysis receipt to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after last receipt of dialysis and remains free of dialysis. If the patient is receiving dialysis at day 28 or dies prior to day 28, VFD will be 0.
Time frame: 28 days
Peak Creatinine in the First 30 Days
Highest creatinine value in the first 30 days
Time frame: 30 days
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