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

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ClinicalTrials.gov Identifier: NCT02565420
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Kamal Maheshwari, MD MPH, The Cleveland Clinic

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.


Condition or disease Intervention/treatment Phase
Postoperative Complications Other: Normal saline Other: Lactated Ringer's solution Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8616 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Alternating intervention
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial
Study Start Date : September 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Active Comparator: Lactated Ringer's solution
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
Patients will be administered Lactated Ringer's solution for intraoperative fluid management.

Placebo Comparator: normal saline
During the perioperative period of the colorectal, orthopedic or similar surgery the patient will receive an intervention of normal saline solution.
Other: Normal saline
Patients will be administered normal saline for intraoperative fluid management.




Primary Outcome Measures :
  1. Major Post Operative Complications [ Time Frame: After surgery through hospital discharge ]
    Major complications include in-hospital mortality, renal (AKIN criteria 2+), respiratory, infectious, and hematological complications.


Secondary Outcome Measures :
  1. Economic evaluation [ Time Frame: After surgery through hospital discharge ]
    The evaluation will determine the incremental costs between the two interventions; uncomplicated care and care of complications, as well as a combined incremental cost.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565420


Locations
United States, Ohio
General Anesthesia, Anesthesia Institute
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: Daniel Sessler, M.D. Chair, Outcomes Research

Responsible Party: Kamal Maheshwari, MD MPH, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02565420     History of Changes
Other Study ID Numbers: 15-858
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes
Pharmaceutical Solutions