Spinal SurgeryNCT01855542
The Aim of This Investigation is to Compare the Influence of 0.9% Saline and Plasmalyte Solution on Acid-base Balance and Electrolytes in Healthy Patients Undergoing Major Spine Surgeries.
A study testing 0.9% normal saline and plasmalyte in people with Spinal Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance and metabolic acidosis in critically ill patients. The aim of this investigation is to compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and electrolytes in healthy patients undergoing major… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Surgery
- What is being tested?
- 0.9% normal saline and plasmalyte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Jan 2013
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.50 patients (aged 20-65) undergoing cervical or lumbar spine surgery who were diagnosed spinal stenosis involving more than tow spinal levels.
Who cannot join
- ASA class III or IV
- pregnancy
- breast feeding
- lack of mental weakness(including disabled)
- using diuretics
- respiratory insufficiency
Show all 14Show fewer
- metabolic acidosis or alkalosis
- coagulation disorder
- over hydtration
- renal failure or serum creatinine > 1.4mg/dl
- anemia (Hemoglobin 9.0<mg/dl)
- hypernatremia (Na > 145mEq/L)
- Hyperkalemia (K>5.5mEq/L)
- psychological medication or any drugs that influences renal clearance
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
Chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance and metabolic acidosis in critically ill patients. The aim of this investigation is to compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and electrolytes in healthy patients undergoing major spine surgeries.
- Conditions
- Spinal Surgery
- Being tested
- 0.9% normal saline, plasmalyte
- Keywords
- metabolic acidosis, plasmalyte solution, 0.9% normal saline
- Medical subject headings
- Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% normal salineOther
In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
plasmalyteOther
In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| 0.9% saline | Experimental | In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery. Receives: Other: 0.9% normal saline |
| plasmalyte | Active comparator | In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery. Receives: Other: plasmalyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
base-excess
Measured: Change from baseline in base-excess at postoperative 12 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startMar 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855542
- Sponsor's protocol ID
- 4-2012-0059
- Status last verified
- May 2013
- First submitted
- 7 May 2013
- Last updated
- 16 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Song JW, Shim JK, Kim NY, Jang J, Kwak YL. The effect of 0.9% saline versus plasmalyte on coagulation in patients undergoing lumbar spinal surgery; a randomized controlled trial. Int J Surg. 2015 Aug;20:128-34. doi: 10.1016/j.ijsu.2015.06.065. Epub 2015 Jun 27.
PubMed 26123384
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Aim of This Investigation is to Compare the Influence of 0.9% Saline and Plasmalyte Solution on Acid-base Balance and Electrolytes in Healthy Patients Undergoing Major Spine Surgeries.
- ClinicalTrials.gov ID
- NCT01855542
- Acronym / sponsor ID
- 4-2012-0059
- Conditions
- Spinal Surgery
- Keywords
- metabolic acidosis, plasmalyte solution, 0.9% normal saline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 May 2013 (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.
Chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance and metabolic acidosis in critically ill patients. The aim of this investigation is to compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and electrolytes in healthy patients undergoing major spine surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.9% saline | Experimental | Other: 0.9% normal salineIn each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery. |
| plasmalyte | Active comparator | Other: plasmalyteIn each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.50 patients (aged 20-65) undergoing cervical or lumbar spine surgery who were diagnosed spinal stenosis involving more than tow spinal levels.
Key exclusion criteria (14 listed)
- ASA class III or IV
- pregnancy
- breast feeding
- lack of mental weakness(including disabled)
- using diuretics
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 |
|---|---|---|
| 0.9% normal salineIn each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery. | Other | 0.9% saline |
| plasmalyteIn each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery. | Other | plasmalyte |
Primary outcome
base-excess
Time frame: Change from baseline in base-excess at postoperative 12 h
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 16 May 2013.
- Derived from this study: PubMed 26123384Song JW, Shim JK, Kim NY, Jang J, Kwak YL. The effect of 0.9% saline versus plasmalyte on coagulation in patients undergoing lumbar spinal surgery; a randomized controlled trial. Int J Surg. 2015 Aug;20:128-34. doi: 10.1016/j.ijsu.2015.06.065. Epub 2015 Jun 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.9% normal saline and plasmalyte in people with Spinal Surgery, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 14 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 16 May 2013. 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 South Korea. 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. 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?
base-excess (time frame: Change from baseline in base-excess at postoperative 12 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01855542, which also lists 1 linked publication.
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 16 May 2013.