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

NCT02565420 | Completed

• 1 other identifier: 15-858
• Study Type: interventional
• Target: 8,616
• Locations: 1 country
• Sites: 1

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. 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. 2.Secondary hypothesis that acute kidney injury, measured by AKIN criteria, is lower in patients given lactated Ringer's solution compared to normal saline.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Economic evaluation

  After surgery through hospital discharge

Study Arms (2)

Lactated Ringer's solution

ACTIVE COMPARATOR

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

normal saline

PLACEBO COMPARATOR

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

Other: Normal saline

Interventions

Normal saline OTHER

Patients will be administered normal saline for intraoperative fluid management.

normal saline

Lactated Ringer's solution OTHER

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

Lactated Ringer's solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having colorectal or similar surgery
• Patients having orthopedic or similar surgery
• Patients 18 years and older

You may not qualify if:

• Patients under 18 years of age

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

General Anesthesia, Anesthesia Institute

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Saline Solution; Ringer's Lactate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Daniel Sessler, M.D.

  Chair, Outcomes Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Alternating intervention

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 1, 2015
• Study Start: September 28, 2015
• Primary Completion: October 1, 2018
• Study Completion: January 1, 2019
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

US (1)