Sodium LactatePhase 3LSDNCT04488874
Sodium Lactate and Brain Relaxation (LSD)
A Phase 3 study testing Sodium Lactate and Mannitol 20% Infusion in people with Sodium Lactate and Intracranial Hypertension, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Resection surgery of brain tumors by craniotomy requires efficient brain relaxation intraoperatively in order to avoid injuries caused by the brain retractors (such as ischemic-reperfusion and cerebral oedema). The gold standard for the brain relaxation during a surgery is Mannitol 20%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sodium Lactate, Intracranial Hypertension, Brain Relaxation
- What is being tested?
- Sodium Lactate and Mannitol 20% Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2020to 30 Jun 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ASA 1, ASA 2 ou ASA 3, meaning they don't have any unstable comorbidities which could be a threat to life.
- Scheduled surgery for resection of supratentorial brain tumors by craniotomy under general anesthesia
- Unilateral brain tumor
- Deviation of the falx cerebri > 3mm on the preoperative imaging
- Pharmacological brain relaxation required by the neurosurgeon in charge of the patient.
- Patient who has been informed and who signed the free informed consent to participate to the study. Meaning the patient understood the purpose and the procedures required by the study and agreed to participate and obey the requirements and restrictions of this study.
- Affiliation to a social security system or recipient of a such system.
Who cannot join
- Emergency surgery
- Age < 18 years old or > 75 years old
- ASA score IV-V
- Legal incapability or limited legal capacity
- Patient who will unlikely cooperate to the study and/or poor cooperation foreseen by the investigator
- Preoperative Glasgow score < 13
Show all 22Show fewer
- Pregnant woman and/or breastfeeding
- Body index masse< 18 kg.m-2 ou > 30 kg.m-2
- Preoperative hyponatremia < 130mmol/l or hypernatremia > 145 mmol/l
- Osmotherapy in the 24 hours prior to the surgery (Mannitol, Hypertonic saline, Sodium lactate)
- Congestive heart failure
- Moderate ou severe chronic kidney disease, defined by a creatinine clearance (MDRD) < 60 ml/min
- End-stage liver disease (Child Pugh ≥ B7)
- Myasthenia gravis
- External ventricular drain or ventriculoperitoneal shunt of cerebrospinal fluid
- Allergy to Mannitol 20% or one of his excipients
- Allergy to Sodium Lactate or one of his excipients
- Contraindication for propofol
- Allergy to anesthetic agents (propofol, remifentanil, cisatracurium)
- Refusal of consent
- Patient within the exclusion period of another study or planned by the "national file of volunteers"
- Medical history of cognitive disorders or demencia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effectiveness of Hypertonic Sodium Lactate Infusion for Intraoperative Brain Relaxation in Patients Undergoing Scheduled Craniotomy for Supratentorial Brain Tumor Resection: Study Protocol of a Single Center Double-blind Randomized Controlled Phase II Pilot Trial
Resection surgery of brain tumors by craniotomy requires efficient brain relaxation intraoperatively in order to avoid injuries caused by the brain retractors (such as ischemic-reperfusion and cerebral oedema). The gold standard for the brain relaxation during a surgery is Mannitol 20%.
Molar sodium lactate is now used to induce brain relaxation in patients with traumatic brain injury and intracranial hypertension due to its osmotic effect. Furthermore, the injection of sodium lactate may lead to better neuronal metabolism during cerebral aggression, and may participate to the reduction of cerebral oedema and secondary injuries.
Read more
LSD is a pilot randomised trial which tries to assess the interest of intravenous administration of molar Sodium Lactate on the quality of brain relaxation in surgical resection of supratentorial brain tumors by craniotomy.
The primary outcome measure is the quality of brain relaxation, evaluated by neurosurgeon at the opening of the dura, by a validated brain relaxation scale.
Read the detailed description
It's a prospective, comparative, randomised, double blinded study. It will enroll 50 patients undergoing resection surgery of supratentorial brain tumor. They will be randomly divided in 2 groups of 25 patients each : Mannitol 20% and molar Sodium Lactate. The only difference between the 2 groups is the drug used for brain relaxation at the surgical incision : Mannitol or Sodium lactate.
The outcome measures include quality of brain relaxation, need of "rescue" therapy to get an adequate brain relaxation, electrolytes alterations, change in lactate serum level, quantification of post operative brain swelling by MRI, time of extubation, Glasgow Coma Scale, neuropsychological evaluation, blood levels of Protein S100-β, NSE (Neuron-Specific Enolase) and GFAP Glial Fibrillary Acid Protein), morbidity and mortality during 30 days after surgery.
- Conditions
- Sodium Lactate, Intracranial Hypertension, Brain Relaxation
- Being tested
- Sodium Lactate, Mannitol 20% Infusion
- Keywords
- Brain relaxation, Sodium lactate, Mannitol 20%, Neurosurgery
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium LactateDrug
Sodium lactate is administered at 2.5mL/kg during the first surgical incision. Neurosurgeon will evaluate the brain relaxation using a validated scale once the dura is open. A stage 1(perfectly relaxed) or 2((acceptably relaxed) is considered satisfactory.
Sodium Lactate and Mannitol 20% are used at an equimolar dose
Mannitol 20% InfusionDrug
Mannitol 20% is administered intravenously at a dose of 5mL/kg, so 1g/kg, during the first surgical incision. Neurosurgeon will evaluate the brain relaxation using a validated scale once the dura is open. A stage 1(perfectly relaxed) or 2((acceptably relaxed) is considered satisfactory.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Lactate | Experimental | Intravenous Molar Sodium Lactate is administered during the first surgical incision. The dose is 2.5mL/kg. Receives: Drug: Sodium Lactate |
| Mannitol 20% | Active comparator | Intravenous mannitol 20% is administered during the first surgical incision. The dose is 5mL/kg (1g/kg). Receives: Drug: Mannitol 20% Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of brain relaxation
An adequate brain relaxation is evaluated by the neurosurgeon with a stage 1 (perfectly relaxed) or 2 (acceptably relaxed) of the brain swelling score validated by Todd et al. The brain swelling score is a four-point-scale: 1 (normal brain; no swelling); 2 (minimal swelling, but acceptable); 3 (serious swelling but no specific change in management required); or 4 (severe brain swelling requiring some intervention). Todd et al. reported a significant Relationship between intracranial pressure and the brain swelling score. The brain swelling score is the consensual tool used in clinical trials to assess the clinical effectiveness of brain relaxative therapy.
Measured: intraoperative
Secondary outcomes (13)
Necessity for "rescue" therapy
Proportion of patients who needed a "rescue" therapy in order to improve the brain relaxation and to enable the surgery. "Rescue" therapy consists of the administration of an additional dose of Mannitol 20% 0.25g/kg, deepening the anesthesia (BIS between 20 and 40) or the administration of an intravenous dose of Thiopental 5mg/kg.
Measured: intraoperative
Electrolytes alterations
Variations of natremia (mmol/L), kaliemia (mmol/L), pH and serum osmolarity (mosmol/L) after administration of the osmotherapy.
Measured: 30 minutes, 60 minutes, 180 minutes, 24 hours and 48 hours after completion of sodium lactate or mannitol infusion
Changes of lactatemia
Variations of lactatemia (mmol/L) after administration of the osmotherapy
Measured: 30 minutes, 60 minutes, 180 minutes, 24 hours and 48 hours after completion of sodium lactate or mannitol infusion
Volume of post operative brain edema
Measurement of the volume of the post operative brain edema by MRI
Measured: Day 2 after surgery
Glasgow Coma Scale
Assessment of Glasgow coma scale (scale assessing level of conscioussness ranging from 3 = deep unconsciousness to 15 = normal consciousness)
Measured: preoperative, at day 1 and day 2 postoperative
Extubation
Time between the end of anesthesia and extubation (min)
Measured: Within 2 hours after the end of surgery
Neurological recovery
Neurological revcovery will be assessed comparing the results of a battery of validated neurocognitive tests performed the day before surgery and at Day 2 after surgery.
Measured: preoperative and Day 2 after surgery
Protein S100-β
change in blood level of Protein S100-β
Measured: Prior to sodium lactate or mannitol infusion and at 24 hours and at 48 hours after completion of sodium lactate or mannitol infusion
Neuron-Specific Enolase (NSE)
Change in blood level of Neuron-Specific Enolase (NSE)
Measured: Prior to sodium lactate or mannitol infusion and at 24 hours and at 48 hours after completion of sodium lactate or mannitol infusion
Glial Fibrillary Acid Protein (GFAP)
Change in blood level of Neuron-Specific Enolase (NSE)
Measured: Prior to sodium lactate or mannitol infusion and at 24 hours and at 48 hours after completion of sodium lactate or mannitol infusion
Morbidity
Incidence of heart rhythm disorders during the first 48 hours postoperative, intensive care unit length of stay, hospital length of stay, duration of mechanical ventilation, postoperative complications
Measured: Within 30 days after surgery
Mortality
Mortality within 30 days after surgery
Measured: Within 30 days after surgery
Karnofsky performance scale
The Karnofsky performance scale index is an assessment tool for functional impairment. The lower the Karnofsky score, the worst functional impairment, and in most serious illnesses, the worse likelihood of survival. The Karnofsky performance scale ranges from 0 (dead patient) to 100 (normal no complaints, no evidence of disease).
Measured: preoperative and at day 30 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start29 Sep 2020
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sodium LactateStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488874
- Sponsor's protocol ID
- API/2017/81
- Acronym
- LSD
- Status last verified
- Aug 2023
- First submitted
- 8 Apr 2019
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Todd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anesthesiology. 1993 Jun;78(6):1005-20. doi: 10.1097/00000542-199306000-00002.
PubMed 8512094Besch G, Thines L, Bronnert R, Boitel A, Scaringella N, Hammoudi F, Hamdan N, Charpentier H, Villeneuve J, Clairet AL, Vettoretti L, Ferreira D, Berthier F, Pili-Floury S. Clinical effectiveness of intravenous hypertonic sodium lactate infusion for intra-operative brain relaxation in supratentorial brain tumour surgery: A double-blind randomised phase II pilot study. Eur J Anaesthesiol. 2026 May 8. doi: 10.1097/EJA.0000000000002414. Online ahead of print.
PubMed 42109031Besch G, Parmentier AL, Berthier F, Jaeg H, Villeneuve J, Hammoudi F, Scaringella N, Clairet AL, Vettoretti L, Chopard G, Thines L, Ferreira D, Samain E, Pili-Floury S. Clinical effectiveness of hypertonic sodium lactate infusion for intraoperative brain relaxation in patients undergoing scheduled craniotomy for supratentorial brain tumor resection: A study protocol of a single center double-blind randomized controlled phase II pilot trial. Medicine (Baltimore). 2022 Oct 7;101(40):e31038. doi: 10.1097/MD.0000000000031038.
PubMed 36221362
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Hypertonic Sodium Lactate Infusion for Intraoperative Brain Relaxation in Patients Undergoing Scheduled Craniotomy for Supratentorial Brain Tumor Resection: Study Protocol of a Single Center Double-blind Randomized Controlled Phase II Pilot Trial
- ClinicalTrials.gov ID
- NCT04488874
- Acronym / sponsor ID
- LSD / API/2017/81
- Conditions
- Sodium Lactate, Intracranial Hypertension, Brain Relaxation
- Keywords
- Brain relaxation, Sodium lactate, Mannitol 20%, Neurosurgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 28 Jul 2020 (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.
Resection surgery of brain tumors by craniotomy requires efficient brain relaxation intraoperatively in order to avoid injuries caused by the brain retractors (such as ischemic-reperfusion and cerebral oedema). The gold standard for the brain relaxation during a surgery is Mannitol 20%.
Molar sodium lactate is now used to induce brain relaxation in patients with traumatic brain injury and intracranial hypertension due to its osmotic effect. Furthermore, the injection of sodium lactate may lead to better neuronal metabolism during cerebral aggression, and may participate to the reduction of cerebral oedema and secondary injuries.
LSD is a pilot randomised trial which tries to assess the interest of intravenous administration of molar Sodium Lactate on the quality of brain relaxation in surgical resection of supratentorial brain tumors by craniotomy.
The primary outcome measure is the quality of brain relaxation, evaluated by neurosurgeon at the opening of the dura, by a validated brain relaxation scale.
Detailed description
It's a prospective, comparative, randomised, double blinded study. It will enroll 50 patients undergoing resection surgery of supratentorial brain tumor. They will be randomly divided in 2 groups of 25 patients each : Mannitol 20% and molar Sodium Lactate. The only difference between the 2 groups is the drug used for brain relaxation at the surgical incision : Mannitol or Sodium lactate.
The outcome measures include quality of brain relaxation, need of "rescue" therapy to get an adequate brain relaxation, electrolytes alterations, change in lactate serum level, quantification of post operative brain swelling by MRI, time of extubation, Glasgow Coma Scale, neuropsychological evaluation, blood levels of Protein S100-β, NSE (Neuron-Specific Enolase) and GFAP Glial Fibrillary Acid Protein), morbidity and mortality during 30 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Lactate | Experimental | Drug: Sodium LactateIntravenous Molar Sodium Lactate is administered during the first surgical incision. The dose is 2.5mL/kg. |
| Mannitol 20% | Active comparator | Drug: Mannitol 20% InfusionIntravenous mannitol 20% is administered during the first surgical incision. The dose is 5mL/kg (1g/kg). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with ASA 1, ASA 2 ou ASA 3, meaning they don't have any unstable comorbidities which could be a threat to life.
- Scheduled surgery for resection of supratentorial brain tumors by craniotomy under general anesthesia
- Unilateral brain tumor
- Deviation of the falx cerebri > 3mm on the preoperative imaging
- Pharmacological brain relaxation required by the neurosurgeon in charge of the patient.
Key exclusion criteria (22 listed)
- Emergency surgery
- Age < 18 years old or > 75 years old
- ASA score IV-V
- Legal incapability or limited legal capacity
- Patient who will unlikely cooperate to the study and/or poor cooperation foreseen by the investigator
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 |
|---|---|---|
| Sodium LactateSodium lactate is administered at 2.5mL/kg during the first surgical incision. Neurosurgeon will evaluate the brain relaxation using a validated scale once the dura is open. A stage 1(perfectly relaxed) or 2((acceptably relaxed) is considered satisfactory. Sodium Lactate and Mannitol 20% are used at an equimolar dose | Drug | Sodium Lactate |
| Mannitol 20% InfusionMannitol 20% is administered intravenously at a dose of 5mL/kg, so 1g/kg, during the first surgical incision. Neurosurgeon will evaluate the brain relaxation using a validated scale once the dura is open. A stage 1(perfectly relaxed) or 2((acceptably relaxed) is considered satisfactory. | Drug | Mannitol 20% |
Primary outcome
Quality of brain relaxation
Time frame: intraoperative
An adequate brain relaxation is evaluated by the neurosurgeon with a stage 1 (perfectly relaxed) or 2 (acceptably relaxed) of the brain swelling score validated by Todd et al. The brain swelling score is a four-point-scale: 1 (normal brain; no swelling); 2 (minimal swelling, but acceptable); 3 (serious swelling but no specific change in management required); or 4 (severe brain swelling requiring some intervention). Todd et al. reported a significant Relationship between intracranial pressure and the brain swelling score. The brain swelling score is the consensual tool used in clinical trials to assess the clinical effectiveness of brain relaxative therapy.
13 secondary outcomes
Necessity for "rescue" therapy
Time frame: intraoperative
Electrolytes alterations
Time frame: 30 minutes, 60 minutes, 180 minutes, 24 hours and 48 hours after completion of sodium lactate or mannitol infusion
Changes of lactatemia
Time frame: 30 minutes, 60 minutes, 180 minutes, 24 hours and 48 hours after completion of sodium lactate or mannitol infusion
Volume of post operative brain edema
Time frame: Day 2 after surgery
Glasgow Coma Scale
Time frame: preoperative, at day 1 and day 2 postoperative
Extubation
Time frame: Within 2 hours after the end of surgery
Neurological recovery
Time frame: preoperative and Day 2 after surgery
Protein S100-β
Time frame: Prior to sodium lactate or mannitol infusion and at 24 hours and at 48 hours after completion of sodium lactate or mannitol infusion
Neuron-Specific Enolase (NSE)
Time frame: Prior to sodium lactate or mannitol infusion and at 24 hours and at 48 hours after completion of sodium lactate or mannitol infusion
Glial Fibrillary Acid Protein (GFAP)
Time frame: Prior to sodium lactate or mannitol infusion and at 24 hours and at 48 hours after completion of sodium lactate or mannitol infusion
Morbidity
Time frame: Within 30 days after surgery
Mortality
Time frame: Within 30 days after surgery
Karnofsky performance scale
Time frame: preoperative and at day 30 after surgery
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 13 Sep 2023.
- Background: PubMed 8512094Todd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anesthesiology. 1993 Jun;78(6):1005-20. doi: 10.1097/00000542-199306000-00002.
- Derived from this study: PubMed 42109031Besch G, Thines L, Bronnert R, Boitel A, Scaringella N, Hammoudi F, Hamdan N, Charpentier H, Villeneuve J, Clairet AL, Vettoretti L, Ferreira D, Berthier F, Pili-Floury S. Clinical effectiveness of intravenous hypertonic sodium lactate infusion for intra-operative brain relaxation in supratentorial brain tumour surgery: A double-blind randomised phase II pilot study. Eur J Anaesthesiol. 2026 May 8. doi: 10.1097/EJA.0000000000002414. Online ahead of print.
- Derived from this study: PubMed 36221362Besch G, Parmentier AL, Berthier F, Jaeg H, Villeneuve J, Hammoudi F, Scaringella N, Clairet AL, Vettoretti L, Chopard G, Thines L, Ferreira D, Samain E, Pili-Floury S. Clinical effectiveness of hypertonic sodium lactate infusion for intraoperative brain relaxation in patients undergoing scheduled craniotomy for supratentorial brain tumor resection: A study protocol of a single center double-blind randomized controlled phase II pilot trial. Medicine (Baltimore). 2022 Oct 7;101(40):e31038. doi: 10.1097/MD.0000000000031038.
- Individual participant dataSharing planned: Yes
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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 3 study testing Sodium Lactate and Mannitol 20% Infusion in people with Sodium Lactate and Intracranial Hypertension, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 7 inclusion and 22 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 13 Sep 2023. 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 France. 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 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?
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?
Quality of brain relaxation (time frame: intraoperative). 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 NCT04488874, which also lists 3 linked publications.
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 13 Sep 2023.