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ARDSNCT03949738

Cerebrovascular Hemodynamics in Patients With ARDS.

An observational study of ARDS, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ARDS
What is being tested?
Near-infrared spectroscopy-based assessement of cerebral autoregulation.
How many people
66 participants
Where
1 siteGermany
Study dates
1 Dec 2018to 30 Nov 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • ARDS

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätskrankenhaus Hamburg-Eppendorf

    Hamburg, 20246

Other trials in Germany

About this study

Official title: 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.

Conditions
ARDS
Being tested
Near-infrared spectroscopy-based assessement of cerebral autoregulation.
Keywords
Cerebral Autoregulation, Cerebral Hemodynamics, Cognitive Impairment, Near-infrared Spectroscopy
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Near-infrared spectroscopy-based assessement of cerebral autoregulation.Diagnostic test

    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.

Study groups in NCT03949738
Study groupRoleWhat they receive
Adult patients with ARDSAdults patients fulfilling the Berlin criteria for ARDS
Receives: Diagnostic Test: Near-infrared spectroscopy-based assessement of cerebral autoregulation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. COx

    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.

    Measured: Assessment for 60 minutes per day during the acute phase of ARDS (maximum 14 days after ARDS onset).

Secondary outcomes (2)

  1. Cognitive Failures Questionnaire (CFQ)

    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.

    Measured: 3, 6 and 12 months after discharge from ICU.

  2. The Short Form (36) Health Survey (SF-36)

    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.

    Measured: 3, 6 and 12 months after discharge from ICU.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2019
  2. Study start1 Dec 2018
  3. Primary completion30 Nov 2019
  4. Study completion30 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03949738
Sponsor's protocol ID
CAR ARDS
Status last verified
Oct 2021
First submitted
20 Feb 2019
Last updated
26 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thompson BT, Chambers RC, Liu KD. Acute Respiratory Distress Syndrome. N Engl J Med. 2017 Aug 10;377(6):562-572. doi: 10.1056/NEJMra1608077. No abstract available.

    PubMed 28792873

  • Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

    PubMed 26903337

  • Brown SM, Wilson EL, Presson AP, Dinglas VD, Greene T, Hopkins RO, Needham DM; with the National Institutes of Health NHLBI ARDS Network. Understanding patient outcomes after acute respiratory distress syndrome: identifying subtypes of physical, cognitive and mental health outcomes. Thorax. 2017 Dec;72(12):1094-1103. doi: 10.1136/thoraxjnl-2017-210337. Epub 2017 Aug 4.

    PubMed 28778920

  • Hopkins RO, Weaver LK, Collingridge D, Parkinson RB, Chan KJ, Orme JF Jr. Two-year cognitive, emotional, and quality-of-life outcomes in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2005 Feb 15;171(4):340-7. doi: 10.1164/rccm.200406-763OC. Epub 2004 Nov 12.

    PubMed 15542793

  • Schramm P, Closhen D, Felkel M, Berres M, Klein KU, David M, Werner C, Engelhard K. Influence of PEEP on cerebral blood flow and cerebrovascular autoregulation in patients with acute respiratory distress syndrome. J Neurosurg Anesthesiol. 2013 Apr;25(2):162-7. doi: 10.1097/ANA.0b013e31827c2f46.

    PubMed 23211642

  • LASSEN NA. Cerebral blood flow and oxygen consumption in man. Physiol Rev. 1959 Apr;39(2):183-238. doi: 10.1152/physrev.1959.39.2.183. No abstract available.

    PubMed 13645234

  • Zweifel C, Dias C, Smielewski P, Czosnyka M. Continuous time-domain monitoring of cerebral autoregulation in neurocritical care. Med Eng Phys. 2014 May;36(5):638-45. doi: 10.1016/j.medengphy.2014.03.002. Epub 2014 Apr 1.

    PubMed 24703503

  • Bullinger M. [Assessment of health related quality of life with the SF-36 Health Survey]. Rehabilitation (Stuttg). 1996 Aug;35(3):XVII-XXVII; quiz XXVII-XXIX. German.

    PubMed 8975342

  • Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.

    PubMed 7126941

  • Murkin JM, Newman SP, Stump DA, Blumenthal JA. Statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery. Ann Thorac Surg. 1995 May;59(5):1289-95. doi: 10.1016/0003-4975(95)00106-u. No abstract available.

    PubMed 7733754

  • Kahl U, Yu Y, Nierhaus A, Frings D, Sensen B, Daubmann A, Kluge S, Fischer M. Cerebrovascular autoregulation and arterial carbon dioxide in patients with acute respiratory distress syndrome: a prospective observational cohort study. Ann Intensive Care. 2021 Mar 16;11(1):47. doi: 10.1186/s13613-021-00831-7.

    PubMed 33725209

Questions about this trial

What is this clinical trial studying?

An observational study of ARDS, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COx (time frame: Assessment for 60 minutes per day during the acute phase of ARDS (maximum 14 days after ARDS onset).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03949738, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.

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