Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit
| 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: | June 1, 2015 |
| End Date: | June 30, 2017 |
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-MED will be a
large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from
the Medical ICU at Vanderbilt University from June 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-MED will be a
large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from
the Medical ICU at Vanderbilt University from June 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-MED 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 the
medical intensive care unit. Between June 2015 and April 2017, all patients admitted to the
medical intensive care unit at Vanderbilt University medical center who are 18 years or older
will be enrolled. The study will occur in one-month blocks. The ICU will be randomized to an
initial fluid group (0.9% saline or physiologically balanced 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 are assigned to physiologically
balance fluid. It is anticipated that around 5,300 patients will be enrolled from the medical
ICU during the study period. All aspects of study design, intervention, and data collection
will be harmonized with an independent study addressing the same question in the non-medical
intensive care units at Vanderbilt University during a similar study period (SMART-SURG). 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 the
medical intensive care unit. Between June 2015 and April 2017, all patients admitted to the
medical intensive care unit at Vanderbilt University medical center who are 18 years or older
will be enrolled. The study will occur in one-month blocks. The ICU will be randomized to an
initial fluid group (0.9% saline or physiologically balanced 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 are assigned to physiologically
balance fluid. It is anticipated that around 5,300 patients will be enrolled from the medical
ICU during the study period. All aspects of study design, intervention, and data collection
will be harmonized with an independent study addressing the same question in the non-medical
intensive care units at Vanderbilt University during a similar study period (SMART-SURG). A
pre-specified data analysis plan will dictate the harmonized analysis of SMART-MED and
SMART-SURG.
Inclusion Criteria:
- Admitted to the 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, M.D., M.Sc.
Phone: 615-802-8428
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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