Cerebral PerfusionNCT02806492
Parameters of Cerebral Perfusion
A study testing 50-100ug phenylephrine before CPB, 50-100ug phenylephrine during CPB and decreasing CPB flow in people with Cerebral Perfusion and Cerebral Oxygenation, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether cerebral blood flow and cerebral tissue oxygenation is most dependent on cardiac output or on mean arterial pressure in patients undergoing cardiac surgery with the use of cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Perfusion, Cerebral Oxygenation, Cardiopulmonary Bypass
- What is being tested?
- 50-100ug phenylephrine before CPB, 50-100ug phenylephrine during CPB and decreasing CPB flow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2016to 17 Mar 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing cardiopulmonary bypass for CABG a
- having an appropriate temporal bone window for reliable TCD monitoring
- needing pharmacological intervention because of hypotension before going on CPB.
Who cannot join
- requiring hypothermia during surgery
- requiring emergency surgery
- contraindication for phenylephrine,
- having known brain pathology (e.g. Cerebral Vascular Accident (CVA) or increased intracranial pressure
- having a history of severe carotid artery stenosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Pressure or Cardiac Output - the Influence on Cerebral Perfusion During Cardiopulmonary Bypass
The purpose of this study is to determine whether cerebral blood flow and cerebral tissue oxygenation is most dependent on cardiac output or on mean arterial pressure in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.
- Being tested
- 50-100ug phenylephrine before CPB, 50-100ug phenylephrine during CPB, decreasing CPB flow, Decreasing CPB flow AND 50-100ug phenylephrine, Increasing CPB flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50-100ug phenylephrine before CPBOther
In this intervention we will administer 50-100 μg phenylephrine to the patient before CPB is started. This intervention will take place when the patient shows hypotension (MAP <60mmHg, according to protocol22). Because of the increase in PVR there will be a baroreceptor-reflex-mediated decrease in CO. On-line, we will quantify the percentage decrease in systemic blood flow (i.e. CO) by using the Modelflow algoritm incorporated in a non-invasive beat-to-beat finger blood pressure monitor. This will allow us to obtain a reference for the decrease in CO to use in the next interventions. Our hypothesis is that CO will decrease because of the baroreceptor-reflex. During this intervention NIRS and TCD MCA will be recorded.
50-100ug phenylephrine during CPBOther
In this intervention we will induce only 1 component of the changes at intervention (1), being the increase in MAP of approximately 20 mmHg by administrating 50-100 μg phenylephrine. The CPB enables us to maintain a constant CO and thus eliminating the baroreceptor-reflex. During this intervention NIRS and TCD MCA will be recorded.
decreasing CPB flowOther
With this intervention we will only create a change in CO, which enables us to eliminate the effect of blood pressure. We will modify CPB flow to achieve the CO decrease (in %) measured at intervention (1) meaning: pre-CPB after the bolus of 50-100 μg phenylephrine. In the case of unexpected increase (in %) of CO measured at intervention (1), we will still decrease CPB flow so we will be able to analyse decrease as well as increase in CPB flow. During this intervention NIRS and TCD MCA will be recorded.
Decreasing CPB flow AND 50-100ug phenylephrineOther
In this intervention we will simulate the 'normal' physiological state when administering phenylephrine. We will modify CPB flow to achieve the percentage change CO as observed during intervention (1) as well as administrate 50-100 μg phenylephrine. We expect to see similar outcomes as in intervention (1). During this intervention NIRS and TCD MCA will be recorded.
Increasing CPB flowOther
In this last intervention we will create an increase in MAP without using phenylephrine but only by increasing CO. This enables us to eliminate a possible direct α1-adrenergic effect on the cerebral vasculature. MAP will be raised approximately 20 mmHg by increasing CPB flow 20%. During this intervention NIRS and TCD MCA will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Patient for cardiac surgery | Experimental | All patient undergo the 5 different intervention in a randomised matter. Receives: Other: 50-100ug phenylephrine before CPB; Other: 50-100ug phenylephrine during CPB; Other: decreasing CPB flow; Other: Decreasing CPB flow AND 50-100ug phenylephrine; Other: Increasing CPB flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
regional cerebral oxygen saturation
Measured: During surgery
mean velocity of blood flow of the middle cerebral artery
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJan 2016
- Primary completion17 Mar 2017
- Study completion17 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PerfusionStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. B. van Zaane, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806492
- Sponsor's protocol ID
- NL48417.041.14
- Status last verified
- Jun 2017
- First submitted
- 15 Jun 2016
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure or Cardiac Output - the Influence on Cerebral Perfusion During Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02806492
- Acronym / sponsor ID
- NL48417.041.14
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 20 Jun 2016 (estimated)
- 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 purpose of this study is to determine whether cerebral blood flow and cerebral tissue oxygenation is most dependent on cardiac output or on mean arterial pressure in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient for cardiac surgery | Experimental | Other: 50-100ug phenylephrine before CPB, Other: 50-100ug phenylephrine during CPB, Other: decreasing CPB flow, Other: Decreasing CPB flow AND 50-100ug phenylephrine, Other: Increasing CPB flowAll patient undergo the 5 different intervention in a randomised matter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing cardiopulmonary bypass for CABG a
- having an appropriate temporal bone window for reliable TCD monitoring
- needing pharmacological intervention because of hypotension before going on CPB.
Key exclusion criteria (5 listed)
- requiring hypothermia during surgery
- requiring emergency surgery
- contraindication for phenylephrine,
- having known brain pathology (e.g. Cerebral Vascular Accident (CVA) or increased intracranial pressure
- having a history of severe carotid artery stenosis.
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 |
|---|---|---|
| 50-100ug phenylephrine before CPBIn this intervention we will administer 50-100 μg phenylephrine to the patient before CPB is started. This intervention will take place when the patient shows hypotension (MAP <60mmHg, according to protocol22). Because of the increase in PVR there will be a baroreceptor-reflex-mediated decrease in CO. On-line, we will quantify the percentage decrease in systemic blood flow (i.e. CO) by using the Modelflow algoritm incorporated in a non-invasive beat-to-beat finger blood pressure monitor. This will allow us to obtain a reference for the decrease in CO to use in the next interventions. Our hypothesis is that CO will decrease because of the baroreceptor-reflex. During this intervention NIRS and TCD MCA will be recorded. | Other | Patient for cardiac surgery |
| 50-100ug phenylephrine during CPBIn this intervention we will induce only 1 component of the changes at intervention (1), being the increase in MAP of approximately 20 mmHg by administrating 50-100 μg phenylephrine. The CPB enables us to maintain a constant CO and thus eliminating the baroreceptor-reflex. During this intervention NIRS and TCD MCA will be recorded. | Other | Patient for cardiac surgery |
| decreasing CPB flowWith this intervention we will only create a change in CO, which enables us to eliminate the effect of blood pressure. We will modify CPB flow to achieve the CO decrease (in %) measured at intervention (1) meaning: pre-CPB after the bolus of 50-100 μg phenylephrine. In the case of unexpected increase (in %) of CO measured at intervention (1), we will still decrease CPB flow so we will be able to analyse decrease as well as increase in CPB flow. During this intervention NIRS and TCD MCA will be recorded. | Other | Patient for cardiac surgery |
| Decreasing CPB flow AND 50-100ug phenylephrineIn this intervention we will simulate the 'normal' physiological state when administering phenylephrine. We will modify CPB flow to achieve the percentage change CO as observed during intervention (1) as well as administrate 50-100 μg phenylephrine. We expect to see similar outcomes as in intervention (1). During this intervention NIRS and TCD MCA will be recorded. | Other | Patient for cardiac surgery |
| Increasing CPB flowIn this last intervention we will create an increase in MAP without using phenylephrine but only by increasing CO. This enables us to eliminate a possible direct α1-adrenergic effect on the cerebral vasculature. MAP will be raised approximately 20 mmHg by increasing CPB flow 20%. During this intervention NIRS and TCD MCA will be recorded. | Other | Patient for cardiac surgery |
Primary outcome
regional cerebral oxygen saturation
Time frame: During surgery
mean velocity of blood flow of the middle cerebral artery
Time frame: During 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 8 Jun 2017.
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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 50-100ug phenylephrine before CPB, 50-100ug phenylephrine during CPB and decreasing CPB flow in people with Cerebral Perfusion and Cerebral Oxygenation, run by UMC Utrecht at 1 site in Netherlands.
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 5 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 8 Jun 2017. 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 Netherlands. 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?
regional cerebral oxygen saturation (time frame: During surgery). The study lists 2 primary outcomes in all. 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 8 Jun 2017.