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出境医 / 临床实验 / Cerebrovascular Hemodynamics in Patients With ARDS.

Cerebrovascular Hemodynamics in Patients With ARDS.

Study Description
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.


Condition or disease Intervention/treatment
ARDS Diagnostic Test: Near-infrared spectroscopy-based assessement of cerebral autoregulation.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cerebrovascular Hemodynamics and Neurocognitive Outcome in Patients With Acute Respiratory Distress Syndrome.
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : January 30, 2021
Arms 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.
Outcome Measures
Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of the intensive care unit of the university hospital Hamburg-Eppendorf diagnosed with ARDS.
Criteria

Inclusion Criteria:

  • ARDS

Exclusion Criteria:

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

Locations
Layout table for location information
Germany
Universitätskrankenhaus Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Tracking Information
First Submitted Date February 20, 2019
First Posted Date May 14, 2019
Last Update Posted Date June 16, 2020
Actual Study Start Date December 1, 2018
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2019) 		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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 13, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cerebrovascular Hemodynamics in Patients With ARDS.
Official Title Cerebrovascular Hemodynamics and Neurocognitive Outcome in Patients With Acute Respiratory Distress Syndrome.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients of the intensive care unit of the university hospital Hamburg-Eppendorf diagnosed with ARDS.
Condition ARDS
Intervention 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.
Study Groups/Cohorts Adult patients with ARDS
Adults patients fulfilling the Berlin criteria for ARDS
Intervention: Diagnostic Test: Near-infrared spectroscopy-based assessement of cerebral autoregulation.
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. Review.
  • 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. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.
  • 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.
  • 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. Epub 2004 Nov 12.
  • 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.
  • LASSEN NA. Cerebral blood flow and oxygen consumption in man. Physiol Rev. 1959 Apr;39(2):183-238.
  • 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. Review.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: June 14, 2020) 		66
Original Estimated Enrollment
 (submitted: May 13, 2019) 		50
Estimated Study Completion Date January 30, 2021
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • ARDS

Exclusion Criteria:

  • Pre-existing neurological diseases with known intracranial pathology
  • Cerebrovascular disorders, including hemodynamically relevant extracranial vascular stenoses
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03949738
Other Study ID Numbers CAR ARDS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborators Not Provided
Investigators Not Provided
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date June 2020

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