Isotonic Solutions and Major Adverse Renal Events Trial in the Non-Medical Intensive Care Unit (SMART-SURG)
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Hospital |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/15/2017 |
| Start Date: | October 1, 2015 |
| End Date: | June 30, 2017 |
Isotonic Solutions and Major Adverse Renal Events Trial in Non-Medical Intensive Care Units
The administration of intravenous fluids is ubiquitous in the care of the critically ill.
Commonly available isotonic crystalloid solutions contain a broad spectrum 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. SMART-SURG will be
a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from
the non-medical ICUs at Vanderbilt University from October 2015 until April 2017. The primary
endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment
(MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at
discharge).
Commonly available isotonic crystalloid solutions contain a broad spectrum 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. SMART-SURG will be
a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from
the non-medical ICUs at Vanderbilt University from October 2015 until April 2017. The primary
endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment
(MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at
discharge).
SMART-SURG is a large, cluster-randomized, multiple-crossover trial of 0.9% saline versus
physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasma-Lyte© A) with
regard to the incidence of major adverse kidney events by 30 days in patients admitted to
non-medical intensive care units. All patients admitted to participating non-medical
intensive care units at Vanderbilt University medical center who are 18 years or older will
be enrolled. The study will occur in one-month blocks. Each participating ICU will be
randomized to an initial fluid group (0.9% saline or physiologically balanced isotonic
crystalloids). The assigned fluid will be used exclusively for all patients receiving
isotonic crystalloid for the duration of the month-long block (except in the presence of
pre-specified contraindications). The assigned study fluid will switch at the end of each
month-long block such that half of the months are assigned to 0.9% saline and half of the
months to physiologically balance fluid. The primary endpoint will be major adverse kidney
events by 30 days (MAKE30 is the composite of death, new renal replacement therapy, or
persistent renal dysfunction at discharge). All aspects of study design, intervention, and
data collection will be harmonized with an ongoing, independent study addressing the same
question in the medical intensive care unit at Vanderbilt University during a similar study
period (SMART-MED). A pre-specified data analysis plan will dictate the harmonized analysis
of SMART-MED and SMART-SURG.
physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasma-Lyte© A) with
regard to the incidence of major adverse kidney events by 30 days in patients admitted to
non-medical intensive care units. All patients admitted to participating non-medical
intensive care units at Vanderbilt University medical center who are 18 years or older will
be enrolled. The study will occur in one-month blocks. Each participating ICU will be
randomized to an initial fluid group (0.9% saline or physiologically balanced isotonic
crystalloids). The assigned fluid will be used exclusively for all patients receiving
isotonic crystalloid for the duration of the month-long block (except in the presence of
pre-specified contraindications). The assigned study fluid will switch at the end of each
month-long block such that half of the months are assigned to 0.9% saline and half of the
months to physiologically balance fluid. The primary endpoint will be major adverse kidney
events by 30 days (MAKE30 is the composite of death, new renal replacement therapy, or
persistent renal dysfunction at discharge). All aspects of study design, intervention, and
data collection will be harmonized with an ongoing, independent study addressing the same
question in the medical intensive care unit at Vanderbilt University during a similar study
period (SMART-MED). A pre-specified data analysis plan will dictate the harmonized analysis
of SMART-MED and SMART-SURG.
Inclusion Criteria:
- Admitted to a participating non-medical intensive care unit (ICU) at Vanderbilt
University Medical Center
Exclusion Criteria:
- Age<18 years old
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Todd W Rice, MD, MSc
Phone: 615-802-8428
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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