Intra Cerebral HypertensionPhase 3SLHYSSNCT06110429
Sodium Lactate Versus Hypertonic Saline Solution in the Treatment of Intracranial Hypertensive Episodes in Severe Brain Injured Patients
A Phase 3 study testing Lactate, Sodium and Hypertonic saline in people with Intra Cerebral Hypertension and Lactate Sodium Solution, run by University Hospital, Geneva.
Trial summary
Brain oedema is a major complication of brain injury (TBI). It increases the risk of intracranial hypertension (ICH) and brain hypoxia, leading to an increase in mortality and poor neurologic outcome. Increased water content in the injured brain can be related to a vasogenic or cellular pathway. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intra Cerebral Hypertension, Lactate Sodium Solution
- What is being tested?
- Lactate, Sodium and Hypertonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Jan 2026
- Phase
- Phase 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with an acute, isolated, severe brain injury (SAH, TBI, ICH)
- Glasgow coma score <8
- Monitored using ICP device
- Presenting an episode of intracranial hypertension requiring osmotherapy. ( defined as increase in ICP 25 mmHg which persisted for more than 5 min in the absence of noxious stimulations)
- Informed Consent as documented by signature
Who cannot join
- Pregnant woman
- Bilateral fixed dilatated pupils
- Initial hypernatremia (>155 mmol/l)
- Penetrating head injury
- Active participation to another trial (Clin B, C)
Trial locations and contacts
No sites are listed yet.
About this study
Brain oedema is a major complication of brain injury (TBI). It increases the risk of intracranial hypertension (ICH) and brain hypoxia, leading to an increase in mortality and poor neurologic outcome. Increased water content in the injured brain can be related to a vasogenic or cellular pathway. Osmotherapy, by using mannitol or hypertonic saline (HSS), is recommended and currently administered for the treatment of ICH in this setting. Beside these two usual treatments, sodium lactate (SL), a metabolic and neuroprotective solution, has recently been described as having similar effects on lowering intracranial pressure (ICP). In a previous study, conducted in patients with severe TBI, (1) Ichai et al. reported that a bolus of half-molar SL was as effective than equimolar doses of mannitol to reduce elevated ICP (less refractory ICH and higher and longer reduction of ICH).
Objective(s):
Read more
The purpose of the study is to analyze the effect on ICH of SL compared to a hypertonic saline solution (HSS).
Outcome(s):
The primary endpoint is the efficacy in lowering ICH after 4 h. Secondary endpoints were percentage of successfully treated episodes of intracranial hypertension and neurological status at discharge from ICU.
- Being tested
- Lactate, Sodium, Hypertonic saline
- Keywords
- intracerebral hypertension, lactate sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactate, SodiumDrug
Isovolemic and osmotic infusion Comparison of osmotic agent
Hypertonic salineDrug
Isovolemic and osmotic infusion Comparison of osmotic agent
| Study group | Role | What they receive |
|---|---|---|
| lactate sodium | Experimental | 100 mL of Sodium lactate (Osmolality 2560 mOsm/L) in 15 mins of administration via a central venous catheter Receives: Drug: Lactate, Sodium |
| Hypertonic Saline solution | Active comparator | single infusion of 100 mL of 7.5% saline (osmolarity, 2560 mOsm/L) (HSS group)in 15 mins of administration via a central venous catheter Receives: Drug: Hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial pressure (ICP)
Invasive monitoring of intracranial pressure
Measured: 240 minutes
Secondary outcomes (4)
Percentage of successfully treated episodes
decrease of ICP >5mmHg or level <20mmHg
Measured: 48 hours
Oxygen tissular pressure
In vasive measurement of tissular pressure
Measured: 240 minutes
Neurological status at discharge of ICU
Measurement Glasgow Outcome Scale
Measured: through study completion, an average of 30 days
Number of episodes of intracranial hypertension
Number of episodes of intracranial hypertension
Measured: through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study startJan 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra Cerebral HypertensionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective open randomized single center study comparing Sodium lactate (SL) to Hypertonic Saline Solution (HSS) in brain injured adult ICU
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hervé Quintard, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110429
- Sponsor's protocol ID
- 701546
- Acronym
- SLHYSS
- Status last verified
- Oct 2023
- First submitted
- 18 Apr 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Lactate Versus Hypertonic Saline Solution in the Treatment of Intracranial Hypertensive Episodes in Severe Brain Injured Patients
- ClinicalTrials.gov ID
- NCT06110429
- Acronym / sponsor ID
- SLHYSS / 701546
- Keywords
- intracerebral hypertension, lactate sodium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 31 Oct 2023 (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.
Brain oedema is a major complication of brain injury (TBI). It increases the risk of intracranial hypertension (ICH) and brain hypoxia, leading to an increase in mortality and poor neurologic outcome. Increased water content in the injured brain can be related to a vasogenic or cellular pathway. Osmotherapy, by using mannitol or hypertonic saline (HSS), is recommended and currently administered for the treatment of ICH in this setting. Beside these two usual treatments, sodium lactate (SL), a metabolic and neuroprotective solution, has recently been described as having similar effects on lowering intracranial pressure (ICP). In a previous study, conducted in patients with severe TBI, (1) Ichai et al. reported that a bolus of half-molar SL was as effective than equimolar doses of mannitol to reduce elevated ICP (less refractory ICH and higher and longer reduction of ICH).
Objective(s):
The purpose of the study is to analyze the effect on ICH of SL compared to a hypertonic saline solution (HSS).
Outcome(s):
The primary endpoint is the efficacy in lowering ICH after 4 h. Secondary endpoints were percentage of successfully treated episodes of intracranial hypertension and neurological status at discharge from ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective open randomized single center study comparing Sodium lactate (SL) to Hypertonic Saline Solution (HSS) in brain injured adult ICU
| Arm | Type | Receives |
|---|---|---|
| lactate sodium | Experimental | Drug: Lactate, Sodium100 mL of Sodium lactate (Osmolality 2560 mOsm/L) in 15 mins of administration via a central venous catheter |
| Hypertonic Saline solution | Active comparator | Drug: Hypertonic salinesingle infusion of 100 mL of 7.5% saline (osmolarity, 2560 mOsm/L) (HSS group)in 15 mins of administration via a central venous catheter |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with an acute, isolated, severe brain injury (SAH, TBI, ICH)
- Glasgow coma score <8
- Monitored using ICP device
- Presenting an episode of intracranial hypertension requiring osmotherapy. ( defined as increase in ICP 25 mmHg which persisted for more than 5 min in the absence of noxious stimulations)
- Informed Consent as documented by signature
Key exclusion criteria (5 listed)
- Pregnant woman
- Bilateral fixed dilatated pupils
- Initial hypernatremia (>155 mmol/l)
- Penetrating head injury
- Active participation to another trial (Clin B, C)
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 |
|---|---|---|
| Lactate, SodiumIsovolemic and osmotic infusion Comparison of osmotic agent | Drug | lactate sodium |
| Hypertonic salineIsovolemic and osmotic infusion Comparison of osmotic agent | Drug | Hypertonic Saline solution |
Primary outcome
intracranial pressure (ICP)
Time frame: 240 minutes
Invasive monitoring of intracranial pressure
4 secondary outcomes
Percentage of successfully treated episodes
Time frame: 48 hours
Oxygen tissular pressure
Time frame: 240 minutes
Neurological status at discharge of ICU
Time frame: through study completion, an average of 30 days
Number of episodes of intracranial hypertension
Time frame: through study completion, an average of 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactate, Sodium and Hypertonic saline in people with Intra Cerebral Hypertension and Lactate Sodium Solution, run by University Hospital, Geneva.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Herve Quintard, MD, PhD (+41795532188, herve.quintard@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracranial pressure (ICP) (time frame: 240 minutes). 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 31 Oct 2023; AzTrials last refreshed its copy on 4 Nov 2026.