Cerebrovascular Hemodynamics in Patients With ARDS.

NCT03949738 | Completed

• 1 other identifier: CAR ARDS
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS

Keywords

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

• Cognitive Failures Questionnaire (CFQ)

  3, 6 and 12 months after discharge from ICU.

• The Short Form (36) Health Survey (SF-36)

  3, 6 and 12 months after discharge from ICU.

Study Arms (1)

Adult patients with ARDS

Adults patients fulfilling the Berlin criteria for ARDS

Diagnostic Test: Near-infrared spectroscopy-based assessement of cerebral autoregulation.

Interventions

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.

Adult patients with ARDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ARDS

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätskrankenhaus Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (11)

• 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.

  PMID: 28792873 BACKGROUND

• 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.

  PMID: 26903337 BACKGROUND

• 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.

  PMID: 28778920 BACKGROUND

• 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.

  PMID: 15542793 BACKGROUND

• 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.

  PMID: 23211642 BACKGROUND

• 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.

  PMID: 13645234 BACKGROUND

• 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.

  PMID: 24703503 BACKGROUND

• 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.

  PMID: 8975342 BACKGROUND

• 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.

  PMID: 7126941 BACKGROUND

• 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.

  PMID: 7733754 BACKGROUND

• 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.

  PMID: 33725209 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: May 14, 2019
• Study Start: December 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2020
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)