Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit

Completed · Not applicable

Conditions studied: Critical Illness, Acute Kidney Injury

In brief

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).

Key facts

Study ID

NCT02444988

Run by

Vanderbilt University

People needed

5381

Starts

2015-06-01

Expected to finish

2017-06-30

Last updated by the study team

2019-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admitted to the medical intensive care unit (ICU) at Vanderbilt University Medical Center

You may not qualify if…

• Age<18 years old

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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