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Cerebrovascular Hemodynamics in Patients With ARDS.

Cerebrovascular Hemodynamics and Neurocognitive Outcome in Patients With Acute Respiratory Distress Syndrome.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03949738
Enrollment
66
Registered
2019-05-14
Start date
2018-12-01
Completion date
2020-11-30
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS

Keywords

Cerebral Autoregulation, Cerebral Hemodynamics, Cognitive Impairment, Near-infrared Spectroscopy

Brief summary

The acute respiratory distress syndrome (ARDS) is a life-threatening disease with functional impairment of the lung. It is characterized by an excessive inflammatory response of lung tissue, capillaries, and blood vessels and is associated with high mortality. Patients who survive the acute phase of this critical disease often suffer from long-term physical, psychological, and mental sequelae, as well as persistent cognitive deficits. In healthy individuals, autoregulatory mechanisms of the intracranial blood vessels keep blood supply to the brain independent of fluctuations in systemic blood pressure. In the case of a serious illness, these mechanisms of autoregulation may be impaired, which may favor cerebral hypoperfusion. Impairment of cerebrovascular hemodynamics can lead to neuronal damage in short and long term. The aim of this project is to investigate cerebrovascular autoregulation in adult patients with ARDS and to evaluate the cognitive outcome at 3, 6 and 12 months after discharge from the intensive care unit.

Interventions

DIAGNOSTIC_TESTNear-infrared spectroscopy-based assessement of cerebral autoregulation.

Cerebral autoregulation is assessed using a software that calculates correlation coefficients based on the values of cerebral oxygenation (detected by near-infrared spectroscopy) and invasively measured arterial blood pressure. Correlation coefficients are calculated at 10-second intervals and averaged over a period of 300 seconds, resulting in an autoregulation index (cerebral oxygenation index, COx). The index can range between -1 and +1. It provides information about cerebral autoregulation capacity, with a value below 0.3 indicating intact cerebral autoregulation.

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ARDS

Exclusion criteria

* Pre-existing neurological diseases with known intracranial pathology * Cerebrovascular disorders, including hemodynamically relevant extracranial vascular stenoses

Design outcomes

Primary

MeasureTime frameDescription
COxAssessment for 60 minutes per day during the acute phase of ARDS (maximum 14 days after ARDS onset).Cerebral Oximetry Index (COx) as a moving correlation between arterial blood pressure and cerebral oximetry with a range from -1 to +1. A COx above 0.3 is defined as impaired cerebrovascular autoregulation. The minutes with COX above 0.3 will be assessed.

Secondary

MeasureTime frameDescription
Cognitive Failures Questionnaire (CFQ)3, 6 and 12 months after discharge from ICU.The Cognitive Failures Questionnaire is a self-report scale used to assess forgetfulness or inattention. It contains 25 items that are rated on a 5-point Likert scale, resulting in a total CFQ score varying from 0 to 100, with higher scores indicating more cognitive failures.
The Short Form (36) Health Survey (SF-36)3, 6 and 12 months after discharge from ICU.The SF-36 is a questionnaire used to assess patient-reported health. It contains eight health-related topics. Each topic is rated on a scale from 0 to 100 with lower scores representing more disability.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026