Cerebrovascular CirculationNCT03732651
The Impact of Non-pulsatile Blood Flow on CO2-Reactivity
A study testing alteration of PaCO2 level in people with Cerebrovascular Circulation, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The investigators hypothezised that CO2-reactivity of cerebral vessels is affected by systemic non-pulsatile blood flow. Patients undergoing elective cardiac surgery with CPB were enrolled in this prospective case control study. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Cerebrovascular Circulation
- What is being tested?
- alteration of PaCO2 level
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustria
- Study dates
- 11 Jun 2008to 2 Dec 2013
- Phase
- Interventional
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- undergoing elective cardiac surgery with cardiopulmonary bypass
Who cannot join
- Carotid artery stenosis (> 50%)
- Neurological pathologies
- COPD with CO2 retention
- Women of childbearing age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Non-pulsatile Perfusion on Cerebral Blood Flow and Brain Oxygenation
The investigators hypothezised that CO2-reactivity of cerebral vessels is affected by systemic non-pulsatile blood flow. Patients undergoing elective cardiac surgery with CPB were enrolled in this prospective case control study. Blood flow velocity in the middle cerebral artery as well as regional cerebral oxygenation was determined during step changes of PaCO2 between 30, 40, and 50 mmHg. Measurements were conducted intraoperatively during non-pulsatile as well as postoperatively after admission to the ICU under pulsatile blood flow.
- Conditions
- Cerebrovascular Circulation
- Being tested
- alteration of PaCO2 level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alteration of PaCO2 levelProcedure or surgery
step changes between 30, 40 and 50 mmHg
| Study group | Role | What they receive |
|---|---|---|
| non-pulsatile blood flow | Experimental | Not described Receives: Procedure: alteration of PaCO2 level |
| pulsatile blood flow | Experimental | Not described Receives: Procedure: alteration of PaCO2 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
CO2- Reactivity of cerebral vessels during cardiopulmonary bypass using nonpulsatile blood flow and postoperative on ICU under physiological pulsatile blood flow
Relation between PaCO2 level and cerebral blood flow velocity will be assessed during non-pulsatile and pulsatile blood flow. Measurements will be performed using trancranial doppler to measure flow velocity of the middle cerebral artery. Further, NIRS will be used to measure oxygen saturation of the brain. Measurements will be performed during step changes of PaCO2 (at 30mmHg, 40mmHg and 50mmHg.
Measured: first time-point: intraoperative, during cardiopulmonary bypass, duration up to 300minutes. Second time-point: on ICU, postoperatively under pulsatile blood flow, duration of measurement up to 100minutes for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start11 Jun 2008
- Primary completion11 Oct 2012
- Study completion2 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular CirculationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Each patient served as his own control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Veraar, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732651
- Sponsor's protocol ID
- 1018730
- Status last verified
- Nov 2018
- First submitted
- 30 Oct 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Veraar CM, Rinosl H, Kuhn K, Skhirtladze-Dworschak K, Felli A, Mouhieddine M, Menger J, Pataraia E, Ankersmit HJ, Dworschak M. Non-pulsatile blood flow is associated with enhanced cerebrovascular carbon dioxide reactivity and an attenuated relationship between cerebral blood flow and regional brain oxygenation. Crit Care. 2019 Dec 30;23(1):426. doi: 10.1186/s13054-019-2671-7.
PubMed 31888721
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Non-pulsatile Perfusion on Cerebral Blood Flow and Brain Oxygenation
- ClinicalTrials.gov ID
- NCT03732651
- Acronym / sponsor ID
- 1018730
- Conditions
- Cerebrovascular Circulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 11 Jun 2008 (actual)
- Primary completion
- 11 Oct 2012 (actual)
- Study completion
- 2 Dec 2013 (actual)
- First posted
- 6 Nov 2018 (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 investigators hypothezised that CO2-reactivity of cerebral vessels is affected by systemic non-pulsatile blood flow. Patients undergoing elective cardiac surgery with CPB were enrolled in this prospective case control study. Blood flow velocity in the middle cerebral artery as well as regional cerebral oxygenation was determined during step changes of PaCO2 between 30, 40, and 50 mmHg. Measurements were conducted intraoperatively during non-pulsatile as well as postoperatively after admission to the ICU under pulsatile blood flow.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient served as his own control.
| Arm | Type | Receives |
|---|---|---|
| non-pulsatile blood flow | Experimental | Procedure: alteration of PaCO2 level |
| pulsatile blood flow | Experimental | Procedure: alteration of PaCO2 level |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing elective cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (4 listed)
- Carotid artery stenosis (> 50%)
- Neurological pathologies
- COPD with CO2 retention
- Women of childbearing age
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 |
|---|---|---|
| alteration of PaCO2 levelstep changes between 30, 40 and 50 mmHg | Procedure or surgery | non-pulsatile blood flow, pulsatile blood flow |
Primary outcome
CO2- Reactivity of cerebral vessels during cardiopulmonary bypass using nonpulsatile blood flow and postoperative on ICU under physiological pulsatile blood flow
Time frame: first time-point: intraoperative, during cardiopulmonary bypass, duration up to 300minutes. Second time-point: on ICU, postoperatively under pulsatile blood flow, duration of measurement up to 100minutes for each patient
Relation between PaCO2 level and cerebral blood flow velocity will be assessed during non-pulsatile and pulsatile blood flow. Measurements will be performed using trancranial doppler to measure flow velocity of the middle cerebral artery. Further, NIRS will be used to measure oxygen saturation of the brain. Measurements will be performed during step changes of PaCO2 (at 30mmHg, 40mmHg and 50mmHg.
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 6 Nov 2018.
- Derived from this study: PubMed 31888721Veraar CM, Rinosl H, Kuhn K, Skhirtladze-Dworschak K, Felli A, Mouhieddine M, Menger J, Pataraia E, Ankersmit HJ, Dworschak M. Non-pulsatile blood flow is associated with enhanced cerebrovascular carbon dioxide reactivity and an attenuated relationship between cerebral blood flow and regional brain oxygenation. Crit Care. 2019 Dec 30;23(1):426. doi: 10.1186/s13054-019-2671-7.
- Individual participant dataSharing planned: Undecided
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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 study testing alteration of PaCO2 level in people with Cerebrovascular Circulation, run by Medical University of Vienna at 1 site in Austria.
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 1 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 6 Nov 2018. 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 Austria. 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.
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?
CO2- Reactivity of cerebral vessels during cardiopulmonary bypass using nonpulsatile blood flow and postoperative on ICU under physiological pulsatile blood flow (time frame: first time-point: intraoperative, during cardiopulmonary bypass, duration up to 300minutes. Second time-point: on ICU, postoperatively under pulsatile blood flow, duration of measurement up to 100minutes for each patient). 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 NCT03732651, which also lists 1 linked publication.
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 6 Nov 2018.