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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 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 8,616 participants.
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
Interventions
- OTHER Normal saline
- OTHER Lactated Ringer's solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,616 participants |
| Start Date | 2015-09-28 |
| Est. Completion | 2019-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02565420
The ClinicalTrials.gov registry entry for NCT02565420 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 8,616 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT02565420 reports 0 study locations.
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.
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