Cerebrovascular Hemodynamics in Patients With ARDS.

October 24, 2021 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Universitätskrankenhaus Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of the intensive care unit of the university hospital Hamburg-Eppendorf diagnosed with ARDS.

Description

Inclusion Criteria:

  • ARDS

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult patients with ARDS
Adults patients fulfilling the Berlin criteria for ARDS
Diagnostic test: Near-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessment for 60 minutes per day during the acute phase of ARDS (maximum 14 days after ARDS onset).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Failures Questionnaire (CFQ)
Time Frame: 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.
3, 6 and 12 months after discharge from ICU.
The Short Form (36) Health Survey (SF-36)
Time Frame: 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.
3, 6 and 12 months after discharge from ICU.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 24, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAR ARDS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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