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

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Normal saline
Lactated Ringer's solution
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • General Anesthesia, Anesthesia Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lactated Ringer's solution

normal saline

Arm Description

During the perioperative period of the colorectal, orthopedic or similar surgery the patient will receive an intervention of Lactated Ringer's solution fluids.

During the perioperative period of the colorectal, orthopedic or similar surgery the patient will receive an intervention of normal saline solution.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 28, 2015
Last Updated
February 8, 2019
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02565420
Brief Title
Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial
Official Title
Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 28, 2015 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Alternating intervention
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8616 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactated Ringer's solution
Arm Type
Active Comparator
Arm Description
During the perioperative period of the colorectal, orthopedic or similar surgery the patient will receive an intervention of Lactated Ringer's solution fluids.
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
During the perioperative period of the colorectal, orthopedic or similar surgery the patient will receive an intervention of normal saline solution.
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
Patients will be administered normal saline for intraoperative fluid management.
Intervention Type
Other
Intervention Name(s)
Lactated Ringer's solution
Intervention Description
Patients will be administered Lactated Ringer's solution for intraoperative fluid management.
Primary Outcome Measure Information:
Title
Major Post Operative Complications
Description
Major complications include in-hospital mortality, renal (AKIN criteria 2+), respiratory, infectious, and hematological complications.
Time Frame
After surgery through hospital discharge
Secondary Outcome Measure Information:
Title
Economic evaluation
Description
The evaluation will determine the incremental costs between the two interventions; uncomplicated care and care of complications, as well as a combined incremental cost.
Time Frame
After surgery through hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Sessler, M.D.
Organizational Affiliation
Chair, Outcomes Research
Official's Role
Study Chair
Facility Information:
Facility Name
General Anesthesia, Anesthesia Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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

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