N/A
Completed N=10,421
Isotonic Solutions and Major Adverse Renal Events Trial in the Non-Medical Intensive Care Unit (SMART-SURG)
Source: ClinicalTrials.gov NCT02547779 ↗Enrolled (actual)
10,421
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Major Adverse Kidney Event Within 30 Days — 551; 524 Participants — p=<0.05
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Kidney Event Within 30 Days |
551; 524 | <0.05 sig |
| SECONDARY 30-day In-hospital Mortality |
408; 400 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Admitted to a participating non-medical intensive care unit (ICU) at Vanderbilt University Medical Center
Exclusion Criteria
- Age<18 years old
Data sourced from ClinicalTrials.gov (NCT02547779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.