Subarachnoid HemorrhagePhase 2INSPIRENCT05213832
Effect of Inhalatory Sedation in Subarachnoid Hemorrhage
A Phase 2 study testing Isoflurane Inhal Soln in people with Subarachnoid Hemorrhage and Aneurysmal Subarachnoid Hemorrhage, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the effect of inhalational sedation on cerebral perfusion in patients with SAH. It will evaluate whether the administration of isofluorane, by inducing direct vasodilation in the cerebral parenchyma, can improve the cerebral perfusion rates. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Isoflurane Inhal Soln
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jun 2020to 31 Dec 2022
- Phase
- Phase 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age > 18 years old
- Diagnosis of non-traumatic SAH
- Neurological and/or systemic presentation that requires support of vital functions and sedation. This occurs for a WFNS score (World Federation of Neurosurgical Societies) ≥ 3.
- Possibility of ICP monitoring through EVD which is necessary in case of acute hydrocephalous. In case of the neurosurgeon do not indicate the positioning of the EVD, an intraparenchymal catheter will be positioned for the ICP monitoring.
- Patients with vasospasm (area of cerebral blood flow under 30% of the best value detected in the brain of the patients at the first CT scan). This exam will be performed at 2° - 3° day post event.
- Acceptance of informed consent.
Who cannot join
- Documented outcomes of cerebrovascular disease
- Patients with acute heart failure related to ESA
- State of pregnancy
- Patients with CLCR < 30 mL/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Inhalatory Sedation on Cerebral Perfusion in Subarachnoid Hemorrhage
The aim of this study is to evaluate the effect of inhalational sedation on cerebral perfusion in patients with SAH.
It will evaluate whether the administration of isofluorane, by inducing direct vasodilation in the cerebral parenchyma, can improve the cerebral perfusion rates.
Perfusional CT will be used to study the variation of cerebral blood flow to rule out the vasodilatory effect on territories with different cerebrovascular reactivity aggravating the phenomena of distrectual hypoperfusion (theft theory).
- Being tested
- Isoflurane Inhal Soln
- Keywords
- perfusion, isofluorane, inhalatory, sedation
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoflurane Inhal SolnDrug
Administration of isofluorane in patients with severe SAH
| Study group | Role | What they receive |
|---|---|---|
| Inhalatory group | Experimental | Patience with severe SAH (WFNS > 3) are enrolled in the study. In these patients we administered a inhalatory dose of Isofluorane Receives: Drug: Isoflurane Inhal Soln |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow recondtion
The percentage of subjects who had a flow recondition at the second CT at least 50% of the best value detected in the first perfusion CT scan
Measured: 20 minutes
Secondary outcomes (2)
Changes in intracranial pressure during isoflurane delivery
We evaluate if isofluorane create an increase in ICP trough continuous monitoring.
Measured: 20 minutes
Changes in blood pressure during isoflurane delivery
By its vasodilatatore effect, we monitored punctually if mean arterial blood pressure will increase during isofluorane delivery
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start26 Jun 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Berardino, A.O.U. Città della Salute e della Scienza
- Investigators
- Maurizio Berardino, MD, Principal investigator, AOU Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213832
- Sponsor's protocol ID
- 0076379
- Acronym
- INSPIRE
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inhalatory Sedation on Cerebral Perfusion in Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT05213832
- Acronym / sponsor ID
- INSPIRE / 0076379
- Keywords
- perfusion, isofluorane, inhalatory, sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Jan 2022 (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.
The aim of this study is to evaluate the effect of inhalational sedation on cerebral perfusion in patients with SAH.
It will evaluate whether the administration of isofluorane, by inducing direct vasodilation in the cerebral parenchyma, can improve the cerebral perfusion rates.
Perfusional CT will be used to study the variation of cerebral blood flow to rule out the vasodilatory effect on territories with different cerebrovascular reactivity aggravating the phenomena of distrectual hypoperfusion (theft theory).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhalatory group | Experimental | Drug: Isoflurane Inhal SolnPatience with severe SAH (WFNS > 3) are enrolled in the study. In these patients we administered a inhalatory dose of Isofluorane |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age > 18 years old
- Diagnosis of non-traumatic SAH
- Neurological and/or systemic presentation that requires support of vital functions and sedation. This occurs for a WFNS score (World Federation of Neurosurgical Societies) ≥ 3.
- Possibility of ICP monitoring through EVD which is necessary in case of acute hydrocephalous. In case of the neurosurgeon do not indicate the positioning of the EVD, an intraparenchymal catheter will be positioned for the ICP monitoring.
- Patients with vasospasm (area of cerebral blood flow under 30% of the best value detected in the brain of the patients at the first CT scan). This exam will be performed at 2° - 3° day post event.
Key exclusion criteria (4 listed)
- Documented outcomes of cerebrovascular disease
- Patients with acute heart failure related to ESA
- State of pregnancy
- Patients with CLCR < 30 mL/min
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 |
|---|---|---|
| Isoflurane Inhal SolnAdministration of isofluorane in patients with severe SAH | Drug | Inhalatory group |
Primary outcome
Cerebral blood flow recondtion
Time frame: 20 minutes
The percentage of subjects who had a flow recondition at the second CT at least 50% of the best value detected in the first perfusion CT scan
2 secondary outcomes
Changes in intracranial pressure during isoflurane delivery
Time frame: 20 minutes
Changes in blood pressure during isoflurane delivery
Time frame: 20 minutes
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 7 Feb 2024.
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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.
Maurizio Berardino, MD principal investigator
AOU Città della Salute e della Scienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isoflurane Inhal Soln in people with Subarachnoid Hemorrhage and Aneurysmal Subarachnoid Hemorrhage, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
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 6 inclusion and 4 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 7 Feb 2024. 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 Italy. 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 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?
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?
Cerebral blood flow recondtion (time frame: 20 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 7 Feb 2024.