Blood Pressure and Cerebral Blood Flow After Cardiac Arrest

NCT05434910 | Unknown DMC

• 1 other identifier: H-22000181
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Out-Of-Hospital Cardiac Arrest; Post-Cardiac Arrest Syndrome

Keywords

Out-Of-Hospital Cardiac Arrest; Blood pressure; Cerebral blood flow; Cerebral metabolism; Cardiac output; Noradrenaline; Post-Cardiac Arrest Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in internal carotid artery blood flow.

  Change in internal carotid artery blood flow \[ml/min\] as evaluated by duplex ultrasound when MAP is set to 65 and 95 mmHg.

  Evaluations at 2 time points; when MAP is set to 65 and 95 mmHg. The evaluations are separated by approximately 30-60 min.

Secondary Outcomes (8)

• Change in cerebral blood flow.

  Evaluations at 2 time points; when MAP is set to 65 and 95 mmHg. The evaluations are separated by approximately 30-60 min.

• Change in vertebral artery blood flow.

  Evaluations at 2 time points; when MAP is set to 65 and 95 mmHg. The evaluations are separated by approximately 30-60 min.

• Change in arterial to internal jugular venous O2 content difference.

  Blood is sampled 2 time points; when MAP is set to 65 and 95 mmHg. The evaluations are separated by approximately 30-60 min.

• Change in arterial to internal jugular venous lactate concentration difference.

  Blood is sampled 2 time points; when MAP is set to 65 and 95 mmHg. The evaluations are separated by approximately 30-60 min.

• Change in arterial to internal jugular venous glucose concentration difference.

  Blood is sampled 2 time points; when MAP is set to 65 and 95 mmHg. The evaluations are separated by approximately 30-60 min.

Study Arms (1)

Intervention

EXPERIMENTAL

Changes in mean arterial pressure (MAP). In all subjects MAP is temporally adjusted using noradrenaline to the following three levels: * MAP 65 mmHg. * MAP 80 mmHg. * MAP 95 mmHg. When MAP has been stable at the given level for 20 min, measurements are conducted over 5 min. When the measurements are done, the study is finished. The study will last approximately 2 hours. Measurements include internal carotid and vertebral artery blood flow, mean arterial pressure, heart rate, peripheral O2 saturation, cardiac output, left ventricle ejection fraction, frontal lobe and muscle oxygenation, blood velocity in the middle cerebral artery, pupillometry, and arterial, central venous, and internal jugular venous gas variables and blood samples for analysis of metabolomics.

Other: Changes in mean arterial pressure

Interventions

Changes in mean arterial pressure OTHER

MAP set at 65 mmHg for 25 min by infusion of noradrenaline. MAP set at 80 mmHg for 25 min by infusion of noradrenaline. MAP set at 95 mmHg for 25 min by infusion of noradrenaline.

Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients that have had in-hospital cardiac arrest.
• Pregnancy, human chorionic gonadotropin is routinely measured in women \< 60 years of age.
• 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.

Sponsors & Collaborators

• Niels Damkjær Olesen: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Post-Cardiac Arrest Syndrome

Interventions

Arterial Pressure

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Reperfusion Injury; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Pressure; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Niels D Olesen, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels D Olesen, MD, PhD

CONTACT

0045 20262459; nielsdolesen@gmail.com

Christian Hassager, MD DMSc prof

CONTACT

0045 35450572; Christian.Hassager@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: In the study, the infusion rate of noradrenaline will be temporarily adjusted to the following three levels MAP: 65, 80, and 95 mmHg and measurements will be conducted at each level of MAP. See detailed description elsewhere.

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 28, 2022
• Study Start: September 9, 2022
• Primary Completion: August 30, 2023
• Study Completion: January 30, 2024
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

DK (1)