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

Study Overview
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Brief Summary
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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: Primary hypothesis that a composite of major in-hospital postoperative complications is lower in patients given lactated Ringer's solution compared to normal saline. 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.

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

Conditions
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Postoperative Complications

Intervention / Treatment
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* Other: Normal saline
* Other: Lactated Ringer's solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Alternating intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactated Ringer's solution<br>During the perioperative period of the colorectal, orthopedic or similar surgery the patient will receive an intervention of Lactated Ringer's solution fluids. | Other: Lactated Ringer's solution<br>* Patients will be administered Lactated Ringer's solution for intraoperative fluid management.<br>|
| Placebo Comparator: normal saline<br>During the perioperative period of the colorectal, orthopedic or similar surgery the patient will receive an intervention of normal saline solution. | Other: Normal saline<br>* Patients will be administered normal saline for intraoperative fluid management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Post Operative Complications | Major complications include in-hospital mortality, renal (AKIN criteria 2+), respiratory, infectious, and hematological complications. | After surgery through hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic evaluation | The evaluation will determine the incremental costs between the two interventions; uncomplicated care and care of complications, as well as a combined incremental cost. | After surgery through hospital discharge |