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Clinical Trials/NCT03949738
NCT03949738
Completed
Not Applicable

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

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country66 target enrollmentDecember 1, 2018
ConditionsARDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
66
Locations
1
Primary Endpoint
COx
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
November 30, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

COx

Time Frame: Assessment 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 Outcomes

  • The Short Form (36) Health Survey (SF-36)(3, 6 and 12 months after discharge from ICU.)
  • Cognitive Failures Questionnaire (CFQ)(3, 6 and 12 months after discharge from ICU.)

Study Sites (1)

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