Aneurysmal Subarachnoid HemorrhagePhase 1/2ODASNCT04135456
The Optimal Dose of Mannitol for Intraoperative Brain Relaxation During the Operation of Aneurysmal Subarachnoid Hemorrhage
A Phase 1/2 study testing Mannitol in people with Aneurysmal Subarachnoid Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Aneurysmal subarachnoid hemorrhage (aSAH) tended to lead to a sudden increase in intracerebral pressure (ICP), which can cause decreased cerebral perfusion and transient global cerebral ischemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Mannitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2019to 14 Jan 2024
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute subarachnoid hemorrhage
- Patients who underwent frontal-temporal craniotomy pterional approach aneurysm clipping surgery under general anesthesia.
- Patients operated by the same surgeon (Dr. Chen Xiaolin).
Who cannot join
- Patients who do not agree to the surgery.
- Patients who have congestive heart failure and kidney insufficiency.
- Patients who have pre-operative electrolyte imbalance.
- Patients who did not take the frontotemporal pterygoid approach.
- Patients with contraindications to mannitol due to low blood pressure.
- Patients who have had more than 3 days from bleeding to surgery.
Show all 10Show fewer
- Patients with intracranial hematoma.
- Patients with Hunt-Hess grades 4-5.
- Patients who received intravenous mannitol within 6 hours before surgery.
- Patients who underwent ventricle puncture and drainage surgery before surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality
About this study
Official title: Study on the Optimal Dosage of Mannitol in Aneurysmal Subarachnoid Hemorrhage Craniotomy
Aneurysmal subarachnoid hemorrhage (aSAH) tended to lead to a sudden increase in intracerebral pressure (ICP), which can cause decreased cerebral perfusion and transient global cerebral ischemia. Early clipping and coiling of aneurysms and surgical evacuation of intracerebral hematoma were recommended for aSAH patients. However, the high ICP made it difficult to separate the subarachnoid space during the operation. Effective reduction of ICP was the key to the succession of the operation. But there is a lack of consensus on the management of raised ICP in aSAH. Mannitol is widely used to reduce ICP in patients with cerebral edema. The potential mechanism including decreasing the viscosity of the blood improving regional cerebral microvascular flow and oxygenation and increasing intravascular volume due to increased plasma osmolality. The magnitude of the pressure reduction was correlated with the intact intracranial automatic adjustment function. However, the hypochloremic metabolic alkalosis, hypernatremia, hypokalemia and renal failure associated with mannitol overdose must be considered and the effective dose and the duration of its administration were still unknown. The aims of this study were to determine the most appropriate mannitol dose to provide adequate brain relaxation in aSAH patients with the fewest adverse effects.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Mannitol
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
When the neurosurgeon starts the skin incision, 20% mannitol administered through the venous catheter with fulldrip in 5-10 minutes. Neurosurgeons evaluate the degree of brain relaxation after dura opening in 4 point scale (1=bulging brain, 2=firm brain, 3=satisfactorily relaxed, 4=perfectly relaxed).
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Experimental | 0.5g/kg of 20% mannitol administered at skin incision. Receives: Drug: Mannitol |
| Medium dose group | Experimental | 1.0g/kg of 20% mannitol administered at skin incision. Receives: Drug: Mannitol |
| High dose group | Experimental | 1.5g/kg of 20% mannitol administered at skin incision. Receives: Drug: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain relaxation score
The degree of brain relaxation after administration was assessed as four grades.
denoting bulging or the condition that additional methods for brain relaxation are immediately and always required in order to continue the surgical procedure because of brain swelling; firm or the condition that additional methods for brain relaxation are occasionally required to continue the surgical procedure; adequate; perfectly relaxed. All patients received conventional frontotemporal pterional approach, and the time from skin incision to dural opening was constant for 30 minutes. At the time of dural opening, the degree of cerebral relaxation was evaluated, and the satisfactory cerebral relaxation was defined as 3 or 4 points.
Measured: Intraoperative
Secondary outcomes (6)
electrolyte change (potassium)
Check the serum laboratory result of potassium (normal range: 3.4-4.5 mmol/L)
Measured: before the infusion of mannitol and 30 minutes after the administration of the study drug.
electrolyte change (sodium)
Check the serum laboratory result of sodium (normal range: 136-146 mmol/L)
Measured: before the infusion of mannitol and 30 minutes after the administration of the study drug.
electrolyte change (chlorine)
Check the serum laboratory result of chlorine (normal range: 98-106 mmol/L)
Measured: before the infusion of mannitol and 30 minutes after the administration of the study drug.
electrolyte change (calcium)
Check the serum laboratory result of calcium (normal range: 1.15-1.29 mmol/L)
Measured: before the infusion of mannitol and 30 minutes after the administration of the study drug.
Subdural hematoma
Excessive decrease in intracranial pressure may lead to intraoperative or postoperative subdural hematoma formation
Measured: CT scan 6 hours after surgery
modified Rankin Score 3 months after surgery
To evaluate the potential benefits of effective dural lysis and brain relaxation on patient outcomes. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start20 Apr 2019
- Primary completion14 Nov 2023
- Study completion14 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Shuo, Beijing Tiantan Hospital
- Investigators
- Shuo Wang, MD, Principal investigator, Beijing Tiantan HospitalXiaolin Chen, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135456
- Sponsor's protocol ID
- KY 2019-09
- Acronym
- ODAS
- Status last verified
- Nov 2023
- First submitted
- 11 Sep 2019
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Optimal Dosage of Mannitol in Aneurysmal Subarachnoid Hemorrhage Craniotomy
- ClinicalTrials.gov ID
- NCT04135456
- Acronym / sponsor ID
- ODAS / KY 2019-09
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Jan 2024 (estimated)
- First posted
- 22 Oct 2019 (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.
Aneurysmal subarachnoid hemorrhage (aSAH) tended to lead to a sudden increase in intracerebral pressure (ICP), which can cause decreased cerebral perfusion and transient global cerebral ischemia. Early clipping and coiling of aneurysms and surgical evacuation of intracerebral hematoma were recommended for aSAH patients. However, the high ICP made it difficult to separate the subarachnoid space during the operation. Effective reduction of ICP was the key to the succession of the operation. But there is a lack of consensus on the management of raised ICP in aSAH. Mannitol is widely used to reduce ICP in patients with cerebral edema. The potential mechanism including decreasing the viscosity of the blood improving regional cerebral microvascular flow and oxygenation and increasing intravascular volume due to increased plasma osmolality. The magnitude of the pressure reduction was correlated with the intact intracranial automatic adjustment function. However, the hypochloremic metabolic alkalosis, hypernatremia, hypokalemia and renal failure associated with mannitol overdose must be considered and the effective dose and the duration of its administration were still unknown. The aims of this study were to determine the most appropriate mannitol dose to provide adequate brain relaxation in aSAH patients with the fewest adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Drug: Mannitol0.5g/kg of 20% mannitol administered at skin incision. |
| Medium dose group | Experimental | Drug: Mannitol1.0g/kg of 20% mannitol administered at skin incision. |
| High dose group | Experimental | Drug: Mannitol1.5g/kg of 20% mannitol administered at skin incision. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with acute subarachnoid hemorrhage
- Patients who underwent frontal-temporal craniotomy pterional approach aneurysm clipping surgery under general anesthesia.
- Patients operated by the same surgeon (Dr. Chen Xiaolin).
Key exclusion criteria (10 listed)
- Patients who do not agree to the surgery.
- Patients who have congestive heart failure and kidney insufficiency.
- Patients who have pre-operative electrolyte imbalance.
- Patients who did not take the frontotemporal pterygoid approach.
- Patients with contraindications to mannitol due to low blood pressure.
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 |
|---|---|---|
| MannitolWhen the neurosurgeon starts the skin incision, 20% mannitol administered through the venous catheter with fulldrip in 5-10 minutes. Neurosurgeons evaluate the degree of brain relaxation after dura opening in 4 point scale (1=bulging brain, 2=firm brain, 3=satisfactorily relaxed, 4=perfectly relaxed). | Drug | High dose group, Low dose group, Medium dose group |
Primary outcome
Brain relaxation score
Time frame: Intraoperative
The degree of brain relaxation after administration was assessed as four grades. denoting bulging or the condition that additional methods for brain relaxation are immediately and always required in order to continue the surgical procedure because of brain swelling; firm or the condition that additional methods for brain relaxation are occasionally required to continue the surgical procedure; adequate; perfectly relaxed. All patients received conventional frontotemporal pterional approach, and the time from skin incision to dural opening was constant for 30 minutes. At the time of dural opening, the degree of cerebral relaxation was evaluated, and the satisfactory cerebral relaxation was defined as 3 or 4 points.
6 secondary outcomes
electrolyte change (potassium)
Time frame: before the infusion of mannitol and 30 minutes after the administration of the study drug.
electrolyte change (sodium)
Time frame: before the infusion of mannitol and 30 minutes after the administration of the study drug.
electrolyte change (chlorine)
Time frame: before the infusion of mannitol and 30 minutes after the administration of the study drug.
electrolyte change (calcium)
Time frame: before the infusion of mannitol and 30 minutes after the administration of the study drug.
Subdural hematoma
Time frame: CT scan 6 hours after surgery
modified Rankin Score 3 months after surgery
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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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.
Shuo Wang, MD principal investigator
Beijing Tiantan Hospital
Xiaolin Chen, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mannitol in people with Aneurysmal Subarachnoid Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
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 10 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 30 Nov 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Brain relaxation score (time frame: Intraoperative). 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 30 Nov 2023.