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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02565420
Enrollment
8616
Registered
2015-10-01
Start date
2015-09-28
Completion date
2019-01-31
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Brief 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 should standardize perioperative fluid selection.

Interventions

OTHERNormal saline

Patients will be administered normal saline for intraoperative fluid management.

Patients will be administered Lactated Ringer's solution for intraoperative fluid management.

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Alternating intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients having colorectal or similar surgery * Patients having orthopedic or similar surgery * Patients 18 years and older

Exclusion criteria

* Patients under 18 years of age

Design outcomes

Primary

MeasureTime frameDescription
Major Post Operative ComplicationsAfter surgery through hospital dischargeMajor complications include in-hospital mortality, renal (AKIN criteria 2+), respiratory, infectious, and hematological complications.

Secondary

MeasureTime frameDescription
Economic evaluationAfter surgery through hospital dischargeThe evaluation will determine the incremental costs between the two interventions; uncomplicated care and care of complications, as well as a combined incremental cost.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026