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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 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 5,381 participants.

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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).

Interventions

  • OTHER 0.9% Saline
  • OTHER Physiologically-balanced isotonic crystalloid

Trial Details

FieldValue
Enrollment Target 5,381 participants
Start Date 2015-06-01
Est. Completion 2017-06-30
Phase NA

Sponsor

Vanderbilt University

430 total trials

What the Registry Record Tells You About NCT02444988

The ClinicalTrials.gov registry entry for NCT02444988 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 5,381 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which 0.9% Saline is the first listed.

NCT02444988 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.