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

NCT ID: NCT02565420

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8616 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-28
• Study Completion Date: 2019-01-31

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.

Conditions

Postoperative Complications

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Lactated Ringer's solution

Intervention Type: OTHER

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

normal saline

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: OTHER

Patients will be administered normal saline for intraoperative fluid management.

Interventions

Normal saline

Patients will be administered normal saline for intraoperative fluid management.

Intervention Type: OTHER

Lactated Ringer's solution

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Kamal Maheshwari, MD MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Sessler, M.D.

Role: STUDY_CHAIR

Chair, Outcomes Research

Locations

General Anesthesia, Anesthesia Institute

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

15-858

Identifier Type: -

Identifier Source: org_study_id