Cerebral Autoregulation in Patients With Aneurysmal SubArachnoid Haemorrhage

NCT03987139 | Unknown

• 1 other identifier: H-19017185
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is, in patients with aneurysmal subarachnoid haemorrhage in the early phase after ictus, to examine the following:

1. 1.The effect of spontaneous and induced changes on the brain's static and dynamic autoregulation calculated by transcranial Doppler (TCD), ICP and MAP (primary purposes) and ICP and PbtO2;
2. 2.The effect of mild hyper- and hypocapnia as well as of mild hyper- and hypoxia on the brain's static and dynamic autoregulation, ICP and PbtO2;
3. 3.The relationship between brain autoregulation, mild hyper- and hypocapnia, as well as of mild hyper- and hypoxia and metabolism in microdialysate on the one hand and the occurrence of DCI during hospitalization and poor neurological outcome one year after ictus on the other.

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Keywords

cerebral autoregulation

Outcome Measures

Primary Outcomes (1)

• Middle cerebral artery flow velocity (MCAv) + induced hypertension

  Measuring MCAv after induced hypertension

  within 5 days after ictus, for 10 minutes after steady state

Secondary Outcomes (6)

• Intracranial pressure (ICP) + induced hypertension

  within 5 days after ictus

• Partial brain tissue oxygenation (PbtO2) + induced hypertension

  within 5 days after ictus

• Intracranial pressure (ICP) + hyper- and hypocapnia

  within 5 days after ictus, for 10 minutes after steady state

• Partial brain tissue oxygenation (PbtO2) + hyper- and hypocapnia

  within 5 days after ictus, for 10 minutes after steady state

• Intracranial pressure (ICP) + hyper- and hypoxia

  within 5 days after ictus, for 10 minutes after steady state

Study Arms (1)

All patients

OTHER

Patients included in the study.

Other: Hypertension; Other: Hyper- and hypoxia; Other: Hyper- and hypocapnia

Interventions

Hypertension OTHER

Hypertension is induced by an infusion of noradrenaline within acceptable limits Baseline recording (10 minutes) is performed. MAP gradually increases in steps of 5-10 mmHg during ongoing TCD. When the desired maximum MAP is reached, measurement is made at steady state (10 minutes). Noradrenaline infusion is stopped. When MAP is stabilized, new baseline is measured for 10 minutes.

All patients

Hyper- and hypoxia OTHER

The mechanical ventilator is adjusted to mild hypoxia, normoxia and mild hyperoxia. Measurements are made for 10 minutes at normoxia and after steady state is reached, respectively. hyperoxia and hypoxia. Oxygenation is controlled by arterial blood gas before and during steady state.

All patients

Hyper- and hypocapnia OTHER

The mechanical ventilator is adjusted to a delta PaCO2 on the ventilator for both hypocapnia and hypercapnia. Measurements are made for 10 minutes at normocapnia and after steady state is reached, respectively. hyper- and hypocapnia.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admittance to neurointensive care unit, Rigshospitalet
• Age ≥ 18 years old
• Aneurysmal subarachnoid haemorrhage
• Clinical indication for placement of an external ventricular drain
• Measurements can be done within 3 days of ictus
• Closest relatives understand written and spoken danish

You may not qualify if:

• No aneurysm identified
• Conservative og failed treatment of aneurysm
• Pupils dilated and do not react to light
• Expected death within 48 hours
• Acute or chronic diseases associated with impaired autoregulation
• Severe chronic lung failure with a PaCO2 \> 6.5 kPa or PaO2 \< 8 kPa.
• Age ≥ 18 years old;
• Understands written and spoken danish
• Oral and written consent
• No medication expect hay fever medications
• Alcohol consumption within the limits from the danish health care board
• Healthy without previous or current cerebrovascular diseases
• Insonation is possible from the middle cerebral artery

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Neuroanaesthesiology

Copenhagen, Capital Region, 2200, Denmark

Location

Related Publications (23)

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MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Model Details: Intervention is performed once in both patients (after the aneurysm is closed and max. 5 days after ictus) and controls. The procedure consists of the following sessions: 1. Induced hypertension; as well 2. (Only in mechanically ventilated patients) either 1. Mild hyper- and hypocapnia or 2. Mild hyper- and hypoxia. In session 2 (hyper- / hypoxia or hyper- / hypocapnia), patients are randomized to order the interventions.

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: June 15, 2019
• Primary Completion: October 1, 2021
• Study Completion: March 1, 2022
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The approved study protocol will be available upon request until publication of the study results
• Access Criteria: Valid reason and contact with author

Locations

DK (1)