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NCT02345486 · ClinicalTrials.gov registry record · NA

Isotonic Solution Administration Logistical Testing

A NA study, sponsored by Vanderbilt University.

Completed
Registry status
NA
Development phase
974
Enrollment target

NCT02345486: Completed NA study, sponsored by Vanderbilt University.

NCT02345486 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 974 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02345486, a NA study, has completed, sponsored by Vanderbilt University.

COMPLETED
Registry status
NA
Development phase
974 participants
Enrollment target

Study Summary

The administration of intravenous crystalloids is ubiquitous in the care of the critically ill. Commonly available crystalloid solutions contain a broad spectrum of electrolyte compositions including a range of chloride concentrations. Recent studies of associated higher fluid chloride content with acute kidney injury and mortality but no large, randomized trials have been conducted. In preparation for a large, cluster-randomized, multiple-crossover trial comparing 0.9% sodium chloride to physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasmalyte-A) in intensive care unit patients, this pilot study will enroll all patients admitted to the medical intensive care unit at a single tertiary center for a sixth month period. The primary objective will be to test the ability of an electronic order entry tool to ensure administration of assigned study fluid or record contraindications to assigned study fluid. The pilot study will also demonstrate the feasibility of collecting demographic, severity of illness, fluid management, vital sign, laboratory, acute kidney injury and renal replacement therapy, and outcome data in an automated, electronic fashion.

Primary Outcome

Proportion of total intravenous isotonic crystalloid administered during admission to the intensive care unit that is 0.9% sodium chloride, censored at 30 days. The primary outcome was the proportion of intravenous isotonic crystalloid administered in the ICU that was saline. This was a continuous variable calculated for each patient as the volume of saline received divided by volume of saline received plus volume of balanced crystalloids received with a range from 0.0 (no saline received) to 1.

Interventions

  • OTHER 0.9% sodium chloride
  • OTHER Physiologically balanced fluid

Trial Details

FieldValue
Enrollment Target 974 participants
Start Date 2015-02
Est. Completion 2015-06
Phase NA
Vanderbilt University

430 total trials

What the finished NCT02345486 record still lists

NCT02345486 is an interventional study that assigns participants to a tested intervention. The registered 974 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (31% lower).

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

NCT02345486 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02345486 about?

NCT02345486 is a clinical study titled "Isotonic Solution Administration Logistical Testing". The administration of intravenous crystalloids is ubiquitous in the care of the critically ill. Commonly available crystalloid solutions contain a broad spectrum of electrolyte compositions including a range of chloride concentrations. Recent studies of associated higher fluid chloride content with ...

What is the current status of trial NCT02345486?

This trial is currently completed. It is a NA study. The enrollment target is 974 participants. The study started on 2015-02. Estimated completion is 2015-06.

What interventions are being tested in trial NCT02345486?

The interventions under investigation include: 0.9% sodium chloride (OTHER), Physiologically balanced fluid (OTHER).

Who is sponsoring clinical trial NCT02345486?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02345486's enrollment target sits among peer trials

974 123rd of 2000 higher than 1,878 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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Source: ClinicalTrials.gov NCT02345486, the US trial registry maintained by the National Library of Medicine. NCT02345486 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.