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NCT02547779 · ClinicalTrials.gov registry record · NA
Isotonic Solutions and Major Adverse Renal Events Trial in the Non-Medical Intensive Care Unit (SMART-SURG)
A NA study of Critical Illness and Acute Kidney Injury, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 10,421
- Enrollment target
- 1
- Study location
NCT02547779: Completed NA study of Critical Illness and Acute Kidney Injury, sponsored by Vanderbilt University.
NCT02547779 is a NA study of Critical Illness and Acute Kidney Injury that has completed, run by Vanderbilt University. The registered enrollment target is 10,421 participants, above the 3,024-participant average among 91 other Critical Illness trials with a reported enrollment target (245% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02547779, a NA study of Critical Illness and Acute Kidney Injury, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 10,421 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
The primary outcome was the proportion of patients who met one or more criteria for a major adverse kidney event within 30 days - the composite of death, new receipt of renal-replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value ≥200% of the baseline value) - all censored at hospital discharge or 30 days after enrollment, whichever came first.
Conditions Studied
Interventions
- OTHER 0.9% Saline
- OTHER Physiologically-balanced isotonic crystalloid
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,421 participants |
| Start Date | 2015-10-01 |
| Est. Completion | 2017-06-30 |
| Phase | NA |
What the finished NCT02547779 record still lists
NCT02547779 is an interventional study that assigns participants to a tested intervention. Its 10,421 participants enrollment target places it among the larger protocols in the corpus, above the 3,024-participant average among 91 other Critical Illness trials with a reported enrollment target (245% higher).
The record links to 2 conditions, with Critical Illness appearing as the primary indexed condition, and to 2 interventions - of which 0.9% Saline is the first listed.
NCT02547779 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT02547779 about?
NCT02547779 is a clinical study titled "Isotonic Solutions and Major Adverse Renal Events Trial in the Non-Medical Intensive Care Unit (SMART-SURG)". 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 chlo...
What is the current status of trial NCT02547779?
This trial is currently completed. It is a NA study. The enrollment target is 10,421 participants. The study started on 2015-10-01. Estimated completion is 2017-06-30.
What conditions does trial NCT02547779 study?
This clinical trial studies the following conditions: Critical Illness, Acute Kidney Injury.
What interventions are being tested in trial NCT02547779?
The interventions under investigation include: 0.9% Saline (OTHER), Physiologically-balanced isotonic crystalloid (OTHER).
Who is sponsoring clinical trial NCT02547779?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02547779 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02547779's enrollment target sits among peer trials
10,421 3rd of 91 higher than 89 of 91 other Critical Illness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Illness trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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