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NCT02444988 · ClinicalTrials.gov registry record · NA
Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit
A NA study, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 5,381
- Enrollment target
NCT02444988: Completed NA study, sponsored by Vanderbilt University.
NCT02444988 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 5,381 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (283% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02444988, a NA study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 5,381 participants
- Enrollment target
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-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).
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.
Interventions
- OTHER 0.9% Saline
- OTHER Physiologically-balanced isotonic crystalloid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,381 participants |
| Start Date | 2015-06-01 |
| Est. Completion | 2017-06-30 |
| Phase | NA |
What the finished NCT02444988 record still lists
NCT02444988 is an interventional study that assigns participants to a tested intervention. Its 5,381 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (283% higher).
The record links to 0 conditions, and to 2 interventions - of which 0.9% Saline is the first listed.
NCT02444988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02444988 about?
NCT02444988 is a clinical study titled "Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit". 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 NCT02444988?
This trial is currently completed. It is a NA study. The enrollment target is 5,381 participants. The study started on 2015-06-01. Estimated completion is 2017-06-30.
What interventions are being tested in trial NCT02444988?
The interventions under investigation include: 0.9% Saline (OTHER), Physiologically-balanced isotonic crystalloid (OTHER).
Who is sponsoring clinical trial NCT02444988?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02444988's enrollment target sits among peer trials
5,381 24th of 2000 higher than 1,977 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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