Scoliosis IdiopathicPhase 2/3NCT06822374
Hypertonic Saline in Posterior Spinal Fusion
A Phase 2/3 study testing Normosol-R and buffered 2% hypertonic saline in people with Scoliosis Idiopathic and Scoliosis;Congenital, run by Joseph D. Tobias at 1 site in United States.
Trial summary
This is a prospective, randomized study in patients greater than or equal to 10 years of age scheduled for an posterior spinal fusion that requires invasive monitoring of arterial blood pressure. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Scoliosis Idiopathic, Scoliosis;Congenital
- What is being tested?
- Normosol-R and buffered 2% hypertonic saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to May 2028
- Phase
- Phase 2/3
- 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 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients > or = 10 years of age
- ASA 1-3
- Undergoing a PSF procedure requiring two peripheral intravenous infusions and an arterial cannula
Who cannot join
- Arterial cannula is not indicated for the surgical procedure
- Two peripheral intravenous cannulas are not required
- An invasive arterial cannula cannot be placed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of a Buffered 2% Hypertonic Saline Solution During Posterior Spinal Fusion
This is a prospective, randomized study in patients greater than or equal to 10 years of age scheduled for an posterior spinal fusion that requires invasive monitoring of arterial blood pressure. Subjects will be randomized to receive either standard of care Normosol-R or buffered 2% hypertonic saline for intraoperative fluid resuscitation.
The primary objective of this study is to compare intraoperative changes in acid-base status and electrolytes based on the type of fluid administered intraoperatively.
The secondary objective is to compare the volume of fluid required and use of adjunctive volume resuscitation with 5% albumin for intraoperative resuscitation when using standard Normosol-R or a novel buffered 2% saline solution.
- Conditions
- Scoliosis Idiopathic, Scoliosis;Congenital
- Being tested
- Normosol-R, buffered 2% hypertonic saline
- Keywords
- intraoperative fluid resuscitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normosol-RDrug
Standard of care isotonic fluid.
buffered 2% hypertonic salineDrug
A solution containing 2% sodium chloride (NaCl) that is "buffered" by the addition of another salt like sodium acetate.
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic saline | Experimental | Buffered 2% saline solution instead of standard of care isotonic fluid for fluid resuscitation during intraoperative care. Receives: Drug: buffered 2% hypertonic saline |
| Normosol-R | Active comparator | Isotonic solution of balanced electrolytes in water for fluid resuscitation during intraoperative care. Receives: Drug: Normosol-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH
pH level from arterial blood gas.
Measured: Every 1-2 hours during the surgery
Base deficit
Base deficit level from arterial blood gas.
Measured: Every 1-2 hours during the surgery
Sodium
Sodium level from arterial blood gas.
Measured: Every 1-2 hours during the surgery
Ionized calcium
Ionized calcium level from arterial blood gas.
Measured: Every 1-2 hours during the surgery
Potassium
Potassium level from arterial blood gas.
Measured: Every 1-2 hours during the surgery
Secondary outcomes (1)
Fluid volume
Volume of fluid required for intraoperative resuscitation.
Measured: Duration of surgery (approx. 4-6 hrs.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study startDec 2025 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph D. Tobias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph D. Tobias, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822374
- Sponsor's protocol ID
- STUDY00005116
- Status last verified
- Nov 2025
- First submitted
- 31 Jan 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Buffered 2% Hypertonic Saline Solution During Posterior Spinal Fusion
- ClinicalTrials.gov ID
- NCT06822374
- Acronym / sponsor ID
- STUDY00005116
- Conditions
- Scoliosis Idiopathic, Scoliosis;Congenital
- Keywords
- intraoperative fluid resuscitation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 12 Feb 2025 (actual)
- 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.
This is a prospective, randomized study in patients greater than or equal to 10 years of age scheduled for an posterior spinal fusion that requires invasive monitoring of arterial blood pressure. Subjects will be randomized to receive either standard of care Normosol-R or buffered 2% hypertonic saline for intraoperative fluid resuscitation.
The primary objective of this study is to compare intraoperative changes in acid-base status and electrolytes based on the type of fluid administered intraoperatively.
The secondary objective is to compare the volume of fluid required and use of adjunctive volume resuscitation with 5% albumin for intraoperative resuscitation when using standard Normosol-R or a novel buffered 2% saline solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertonic saline | Experimental | Drug: buffered 2% hypertonic salineBuffered 2% saline solution instead of standard of care isotonic fluid for fluid resuscitation during intraoperative care. |
| Normosol-R | Active comparator | Drug: Normosol-RIsotonic solution of balanced electrolytes in water for fluid resuscitation during intraoperative care. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients > or = 10 years of age
- ASA 1-3
- Undergoing a PSF procedure requiring two peripheral intravenous infusions and an arterial cannula
Key exclusion criteria (3 listed)
- Arterial cannula is not indicated for the surgical procedure
- Two peripheral intravenous cannulas are not required
- An invasive arterial cannula cannot be placed
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 |
|---|---|---|
| Normosol-RStandard of care isotonic fluid. | Drug | Normosol-R |
| buffered 2% hypertonic salineA solution containing 2% sodium chloride (NaCl) that is "buffered" by the addition of another salt like sodium acetate. | Drug | Hypertonic saline |
Primary outcome
pH
Time frame: Every 1-2 hours during the surgery
pH level from arterial blood gas.
Base deficit
Time frame: Every 1-2 hours during the surgery
Base deficit level from arterial blood gas.
Sodium
Time frame: Every 1-2 hours during the surgery
Sodium level from arterial blood gas.
Ionized calcium
Time frame: Every 1-2 hours during the surgery
Ionized calcium level from arterial blood gas.
Potassium
Time frame: Every 1-2 hours during the surgery
Potassium level from arterial blood gas.
1 secondary outcome
Fluid volume
Time frame: Duration of surgery (approx. 4-6 hrs.)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
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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 Phase 2/3 study testing Normosol-R and buffered 2% hypertonic saline in people with Scoliosis Idiopathic and Scoliosis;Congenital, run by Joseph D. Tobias 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 3 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: withdrawn, as of the sponsor's last update on 10 Nov 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
pH (time frame: Every 1-2 hours during the surgery). The study lists 5 primary outcomes in all. 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 10 Nov 2025.