Blood Pressure and Cerebral Blood Flow After Cardiac Arrest (NCT05434910) | Clinical Trial Compass
UnknownNot Applicable
Blood Pressure and Cerebral Blood Flow After Cardiac Arrest
Denmark20 participantsStarted 2022-09-09
Plain-language summary
Comatose patients that are admitted to an intensive care unit after out-of-hospital cardiac arrest (OCHA) have a high mortality, particularly due to hypoxic-ischemic neurologic injury. These patients often require vasopressors to maintain mean arterial pressure (MAP), but it is unclear what level of MAP should be aimed for. The objective of the study is to evaluate whether cerebral blood flow (CBF) and cerebral metabolism can be increased by maintaining MAP at a higher level than that used in clinical practice. The study will include twenty comatose patients within two days following resuscitation after OCHA. In the study, MAP is adjusted by infusion of noradrenaline, to a low, moderate, and high level for a short time. The low level of MAP used in the study, corresponds to the level aimed for in clinical practice. The CBF will be evaluated on the neck using ultrasound.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are resuscitated within the last 48 hours after OCHA due to suspected or confirmed cardiac cause.
* Comatose or sedated (Glasgow Coma Score \< 8 whereby the patient is unable to follow verbal commands).
* Age 18-90 years.
Exclusion Criteria:
* Patients that have had in-hospital cardiac arrest.
* Pregnancy, human chorionic gonadotropin is routinely measured in women \< 60 years of age.
* Known hemorrhagic diathesis (medically induced coagulopathy due to blood thinners is not an exclusion criteria, except for those mentioned below).
* Anticoagulant therapy by warfarin with an INR \> 2, Direct-Acting Oral Anticoagulants, or Eptifibatid.
* Suspected or confirmed stroke.
* Non-witnessed cardiac arrest with asystole as the initial rhythm.
* Known treatment limitation plan or a decision not to resuscitate the patient in case of a new cardiac arrest.
* Previous disease that makes 180 day survival unlikely.
* Known Cerebral Performance Category score 3 to 4 prior to cardiac arrest.
* Systolic blood pressure \< 80 mmHg despite optimal fluid-, vasopressor-, and inotropic treatment.
* The need of noradrenaline infusion exceeding 0.3 μg/kg\*min in order to maintain a MAP of 65 mmHg.
* Mechanical cardiac support devices.
* Known vascular disease in the internal carotid artery.
* Lack of visualization of the internal carotid artery, e.g. due to high placement of the bifurcation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in internal carotid artery blood flow.
Timeframe: Evaluations at 2 time points; when MAP is set to 65 and 95 mmHg. The evaluations are separated by approximately 30-60 min.