The Time for Determine CPPoptNCT03879330
NIRS Directed Optimal Cerebral Perfusion Pressure in Aneurysmal Subarachnoid Hemorrhage Patients: A Feasibility Study
An observational study of The Time for Determine CPPopt, run by Xiangya Hospital of Central South University.
Trial summary
Neurologic dysfunction is common in aneurysmal subarachnoid hemorrhage (aSAH) patients. As we know, after the initial injury, secondary insults including poor cerebral perfusion are main contributors to poor outcome and their early detection and amelioration are keystone to neurocritical care. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- The Time for Determine CPPopt
- What is being tested?
- NIRS monitoring
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2019to 31 Dec 2019
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (Age ≥ 18 years) aneurysmal subarachnoid hemorrhage patients (Hunt \& Hess classification≥ 3) who admitted to ICU and predicted to stay in ICU ≥ 24 hours.
Who may be able to join
- Age ≥ 18 years;
- Admitted to ICU because of aSAH (Hunt \& Hess classification≥ 3).
- Predicted to stay in ICU ≥ 24 hours
Who cannot join
- Unable to perform NIRS monitoring because of anatomic factors: such as forehead skin damage, intracranial gas accumulation, severe edema of monitoring sites;
- Patients with severe organ failure: such as poorly controlled chronic hypertension, chronic renal failure.
About this study
Neurologic dysfunction is common in aneurysmal subarachnoid hemorrhage (aSAH) patients. As we know, after the initial injury, secondary insults including poor cerebral perfusion are main contributors to poor outcome and their early detection and amelioration are keystone to neurocritical care. Nonetheless, the guidelines for blood pressure management still recommend a single target blood pressure for critically ill patients: the Brain Trauma Foundation (BTF) guidelines recommend maintaining CPP between 60 and 70 mmHg; Some guidelines recognize that patients with a history of hypertension may require a higher MAP. However, these guidelines do not currently recommend cerebral autoregulation-guided therapy and leave many unanswered questions. Cerebral autoregulation is the mechanism that maintains cerebral blood supply, hence CBF approximately constant despite changes in MAP or, more precisely, despite changes in CPP. Maintaining blood pressure within the cerebral blood flow (CBF) autoregulation range (termed "optimal MAP") is associated with improved outcomes for patients. The observational data suggests that management of patients above or below CPPopt 5mmHg is associated with better outcomes and mortality than the other greater variation range. The most commonly used method for monitoring dynamic cerebrovascular reactivity is the pressure reactivity index (PRx) that uses ICP as a surrogate for CBV. However, assessing the PRx requires invasive ICP monitoring which limits its application in many clinical areas. Alternatively, in the absence of invasive intracranial pressure monitoring to determine CPP, a continuous autoregulation monitoring can be accomplished by the continuous correlation between transcranial Doppler (TCD)-measured CBF velocity of the middle cerebral artery and the mean arterial blood pressure (termed mean velocity index or Mx). Mx is a validated index of cerebral autoregulation based on measures of cerebral perfusion pressure and mean flow velocity on transcranial doppler but is impractical for longer-term monitoring and requires system training, the results are operator-dependent. Near-infrared spectroscopy (NIRS) measurements is another alternative for real-time autoregulation monitoring in the form of a Tissue Oxygenation Index. In contrast to TCD, the NIRS sensors are very easy to apply (the probes attach to the forehead with self-adhesive pads) and do not require frequent calibration making them more suitable for long-term monitoring. Therefore, in this study, Patients in the intervention group will be monitored by continuous NIRS and invasive blood pressure monitoring. The correlation curve between ORI/THx and blood pressure will be obtained through continuous monitoring of 2 hours. According to the correlation curve, the optimal blood pressure which provides the optimal CPP will be determined. Then the optimal blood pressure which CPP is within 5 mmHg of CPPopt will be maintained as the target of blood pressure management for the intervention group during ICU stay.
- Conditions
- The Time for Determine CPPopt
- Being tested
- NIRS monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS monitoringDevice
aSAH patients will be given continuous NIRS and blood pressure monitoring at same time. The correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure will be obtained through continuous monitoring of 4 hours. According to the correlation curve, the optimal blood pressure will be determined which provides the optimal CPP.
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal CPP
the minimal time that CPPopt can be determined by the correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure.
Measured: 16 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Jul 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Time for Determine CPPoptStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879330
- Sponsor's protocol ID
- 2018101083
- Status last verified
- Oct 2018
- First submitted
- 6 Mar 2019
- Last updated
- 12 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIRS Directed Optimal Cerebral Perfusion Pressure in Aneurysmal Subarachnoid Hemorrhage Patients: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03879330
- Acronym / sponsor ID
- 2018101083
- Conditions
- The Time for Determine CPPopt
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 18 Mar 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.
Neurologic dysfunction is common in aneurysmal subarachnoid hemorrhage (aSAH) patients. As we know, after the initial injury, secondary insults including poor cerebral perfusion are main contributors to poor outcome and their early detection and amelioration are keystone to neurocritical care. Nonetheless, the guidelines for blood pressure management still recommend a single target blood pressure for critically ill patients: the Brain Trauma Foundation (BTF) guidelines recommend maintaining CPP between 60 and 70 mmHg; Some guidelines recognize that patients with a history of hypertension may require a higher MAP. However, these guidelines do not currently recommend cerebral autoregulation-guided therapy and leave many unanswered questions. Cerebral autoregulation is the mechanism that maintains cerebral blood supply, hence CBF approximately constant despite changes in MAP or, more precisely, despite changes in CPP. Maintaining blood pressure within the cerebral blood flow (CBF) autoregulation range (termed "optimal MAP") is associated with improved outcomes for patients. The observational data suggests that management of patients above or below CPPopt 5mmHg is associated with better outcomes and mortality than the other greater variation range. The most commonly used method for monitoring dynamic cerebrovascular reactivity is the pressure reactivity index (PRx) that uses ICP as a surrogate for CBV. However, assessing the PRx requires invasive ICP monitoring which limits its application in many clinical areas. Alternatively, in the absence of invasive intracranial pressure monitoring to determine CPP, a continuous autoregulation monitoring can be accomplished by the continuous correlation between transcranial Doppler (TCD)-measured CBF velocity of the middle cerebral artery and the mean arterial blood pressure (termed mean velocity index or Mx). Mx is a validated index of cerebral autoregulation based on measures of cerebral perfusion pressure and mean flow velocity on transcranial doppler but is impractical for longer-term monitoring and requires system training, the results are operator-dependent. Near-infrared spectroscopy (NIRS) measurements is another alternative for real-time autoregulation monitoring in the form of a Tissue Oxygenation Index. In contrast to TCD, the NIRS sensors are very easy to apply (the probes attach to the forehead with self-adhesive pads) and do not require frequent calibration making them more suitable for long-term monitoring. Therefore, in this study, Patients in the intervention group will be monitored by continuous NIRS and invasive blood pressure monitoring. The correlation curve between ORI/THx and blood pressure will be obtained through continuous monitoring of 2 hours. According to the correlation curve, the optimal blood pressure which provides the optimal CPP will be determined. Then the optimal blood pressure which CPP is within 5 mmHg of CPPopt will be maintained as the target of blood pressure management for the intervention group during ICU stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (Age ≥ 18 years) aneurysmal subarachnoid hemorrhage patients (Hunt \& Hess classification≥ 3) who admitted to ICU and predicted to stay in ICU ≥ 24 hours.
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Admitted to ICU because of aSAH (Hunt \& Hess classification≥ 3).
- Predicted to stay in ICU ≥ 24 hours
Key exclusion criteria (2 listed)
- Unable to perform NIRS monitoring because of anatomic factors: such as forehead skin damage, intracranial gas accumulation, severe edema of monitoring sites;
- Patients with severe organ failure: such as poorly controlled chronic hypertension, chronic renal failure.
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 |
|---|---|---|
| NIRS monitoringaSAH patients will be given continuous NIRS and blood pressure monitoring at same time. The correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure will be obtained through continuous monitoring of 4 hours. According to the correlation curve, the optimal blood pressure will be determined which provides the optimal CPP. | Device | – |
Primary outcome
Optimal CPP
Time frame: 16 hours
the minimal time that CPPopt can be determined by the correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of The Time for Determine CPPopt, run by Xiangya Hospital of Central South University.
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 2 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 12 Jun 2019. 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.
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?
Optimal CPP (time frame: 16 hours). 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 12 Jun 2019.