Postoperative ComplicationsNCT02565420
Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial
A study testing Normal saline and Lactated Ringer's solution in people with Postoperative Complications, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Normal saline and Lactated Ringer's solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,616 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2015to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients having colorectal or similar surgery
- Patients having orthopedic or similar surgery
- Patients 18 years and older
Who cannot join
- Patients under 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
General Anesthesia, Anesthesia Institute
Cleveland, Ohio, 44195
About this study
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:
Read more
- 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.
- Conditions
- Postoperative Complications
- Being tested
- Normal saline, Lactated Ringer's solution
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineOther
Patients will be administered normal saline for intraoperative fluid management.
Lactated Ringer's solutionOther
Patients will be administered Lactated Ringer's solution for intraoperative fluid management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Post Operative Complications
Major complications include in-hospital mortality, renal (AKIN criteria 2+), respiratory, infectious, and hematological complications.
Measured: After surgery through hospital discharge
Secondary outcomes (1)
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.
Measured: After surgery through hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start28 Sep 2015
- Primary completionOct 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Alternating intervention
- Masking
- None (open label)
- Enrolment
- 8,616 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamal Maheshwari, MD MPH, The Cleveland Clinic
- Investigators
- Daniel Sessler, M.D., Study chair, Chair, Outcomes Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565420
- Sponsor's protocol ID
- 15-858
- Status last verified
- Feb 2019
- First submitted
- 28 Sep 2015
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial
- ClinicalTrials.gov ID
- NCT02565420
- Acronym / sponsor ID
- 15-858
- Conditions
- Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,616 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 28 Sep 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Alternating intervention
| Arm | Type | Receives |
|---|---|---|
| Lactated Ringer's solution | Active comparator | Other: Lactated Ringer's solutionDuring the perioperative period of the colorectal, orthopedic or similar surgery the patient will receive an intervention of Lactated Ringer's solution fluids. |
| normal saline | Placebo comparator | Other: Normal salineDuring the perioperative period of the colorectal, orthopedic or similar surgery the patient will receive an intervention of normal saline solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients having colorectal or similar surgery
- Patients having orthopedic or similar surgery
- Patients 18 years and older
Key exclusion criteria (1 listed)
- Patients under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal salinePatients will be administered normal saline for intraoperative fluid management. | Other | normal saline |
| Lactated Ringer's solutionPatients will be administered Lactated Ringer's solution for intraoperative fluid management. | Other | Lactated Ringer's solution |
Primary outcome
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.
1 secondary outcome
Economic evaluation
Time frame: After surgery through hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Sessler, M.D. study chair
Chair, Outcomes Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline and Lactated Ringer's solution in people with Postoperative Complications, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Post Operative Complications (time frame: After surgery through hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.