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NCT02565420 · ClinicalTrials.gov registry record · NA

Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial

A NA study, sponsored by The Cleveland Clinic.

Completed
Registry status
NA
Development phase
8,616
Enrollment target

NCT02565420: Completed NA study, sponsored by The Cleveland Clinic.

NCT02565420 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 8,616 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (514% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02565420, a NA study, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
NA
Development phase
8,616 participants
Enrollment target

Study Summary

Perioperative volumes of saline cause a mild acidosis compared with buffered fluids. On the other hand, saline administration maintains plasma osmolality and better repletes vascular volume which is an important goal of perioperative fluid administration. Currently, there is no convincing evidence that either saline or buffered solutions are preferable. Consequently, both types of fluid remain in common use at the Clinic and worldwide. There has never been a large trial of perioperative saline and balanced salt solutions comparing the incidence of major complications including acute kidney injury. The investigators primary objective is thus to determine the relative safety of perioperative saline and lactated Ringer's solution. Specifically, the investigators propose to test the: 1. Primary hypothesis that a composite of major in-hospital postoperative complications is lower in patients given lactated Ringer's solution compared to normal saline. 2. Secondary hypothesis that acute kidney injury, measured by AKIN criteria, is lower in patients given lactated Ringer's solution compared to normal saline. The acquisition cost of saline and lactated Ringer's solutions is similar in the United States. (Curiously, buffered solutions are far more expensive than saline in Great Britain.) But to the extent that one fluid or the other provokes more complications, cost of care may be increased with that fluid selection. Cost may also be increased by the need for additional electrolyte monitoring and electrolyte replacement. The investigators will therefore secondarily conduct an economic evaluation to determine the relative incremental hospital cost of each fluid. To the extent that one fluid or the other reduces cost (assuming similar complication rates), the Clinic will be able to reduce cost by specifying the appropriate fluid without impairing quality. Evidence that one fluid or the other causes few complications would be a strong quality indicator that the Clinic shoul

Primary Outcome

Major complications include in-hospital mortality, renal (AKIN criteria 2+), respiratory, infectious, and hematological complications.

Interventions

  • OTHER Normal saline
  • OTHER Lactated Ringer's solution

Trial Details

FieldValue
Enrollment Target 8,616 participants
Start Date 2015-09-28
Est. Completion 2019-01
Phase NA
The Cleveland Clinic

688 total trials

What the finished NCT02565420 record still lists

NCT02565420 is an interventional study that assigns participants to a tested intervention. Its 8,616 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (514% higher).

The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.

NCT02565420 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02565420 about?

NCT02565420 is a clinical study titled "Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial". Perioperative volumes of saline cause a mild acidosis compared with buffered fluids. On the other hand, saline administration maintains plasma osmolality and better repletes vascular volume which is an important goal of perioperative fluid administration. Currently, there is no convincing evidence t...

What is the current status of trial NCT02565420?

This trial is currently completed. It is a NA study. The enrollment target is 8,616 participants. The study started on 2015-09-28. Estimated completion is 2019-01.

What interventions are being tested in trial NCT02565420?

The interventions under investigation include: Normal saline (OTHER), Lactated Ringer's solution (OTHER).

Who is sponsoring clinical trial NCT02565420?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02565420's enrollment target sits among peer trials

8,616 18th of 2000 higher than 1,983 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 NCT02565420, the US trial registry maintained by the National Library of Medicine. NCT02565420 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.