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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565420
• Other study ID #: 15-858
• Status: Completed
• Phase: N/A
• Start date: September 28, 2015
• Est. completion date: January 2019

Study information

• Verified date: February 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8616
• Est. completion date: January 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Other:
• Normal saline
Patients will be administered normal saline for intraoperative fluid management.
• Lactated Ringer's solution
Patients will be administered Lactated Ringer's solution for intraoperative fluid management.

Locations

Country	Name	City	State
United States	General Anesthesia, Anesthesia Institute	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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