Long-term Cognitive and Cerebral Changes in Sepsis Survivors and Their Predictors
NCT ID: NCT02339649
Last Updated: 2017-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
308 participants
INTERVENTIONAL
2013-09-30
2019-10-31
Brief Summary
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Detailed Description
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Secondary aims:
* Profiling specific cognitive deficits in sepsis survivors over time.
* Identifying possible subclasses of long-term cognitive impairment according to facets of disease, therapy and ICU experience.
* Investigating long-term brain morphological changes, with hippocampus as region of interest (ROI).
* Determining values of Serum- and CSF-Biomarkers
* Evaluation of diagnostic and prognostic value of non-routine biomarkers for systemic- and neuroinflammation in the acute phase and in the long-term
* Investigate associations between brain morphological changes, cognitive changes, neurological status, psychiatric burden, disability level, employment status and health-related quality of life (HRQOL).
* Investigating brain-activity changes in resting state electro-encephalogram (EEG)
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Sepsis/septic Shock
Men and women seen at the intensive care units of the Anesthesiology Department of the University Hospital Bonn aged 25-80; fulfill the criteria of sepsis and/or septic shock patients according to theThird International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3, Singer et al, 2016).
Interventions: Neurocognitive Assessment, Clinical Scales, Questionnaires, Blood Sample, voluntary Lumbar Puncture, Resting State EEG, MRI
Blood Sample
Blood Sample
Neurocognitive Assessment
Neurocognitive Assessment
Resting State EEG
10-20 Minutes of Resting State EEG
Lumbar Puncture
Lumbar Puncture
MRI
60 Minutes MRI
Postoperative ICU Patients
Men and women seen at the intensive care units of the Anesthesiology Department of the University Hospital Bonn aged 25-80:
* Admitted to the intensive care units of the Anesthesiological-Operative Intensive Care Unit of the University Hospital Bonn, which includes a surgical ICU, an anesthesiological ICU, and a cardio-surgical ICU
* Duration of ICU stay must be a minimum of 24 hours.
* Mini-Mental State Examination (MMSE) Score of 25 or above
Interventions: Neurocognitive Assessment, Clinical Scales, Questionnaires, Blood Sample, voluntary Lumbar Puncture, Resting State EEG, MRI
Blood Sample
Blood Sample
Neurocognitive Assessment
Neurocognitive Assessment
Resting State EEG
10-20 Minutes of Resting State EEG
Lumbar Puncture
Lumbar Puncture
MRI
60 Minutes MRI
Healthy Controls
Healthy Controls will only be included in the study if they meet all of the following criteria: Written informed consent of the subject, Aged 25-80 years, Male or female.
Interventions: Neurocognitive Assessment, Clinical Scales, Questionnaires, Blood Sample, voluntary Lumbar Puncture, Resting State EEG, MRI
Blood Sample
Blood Sample
Neurocognitive Assessment
Neurocognitive Assessment
Resting State EEG
10-20 Minutes of Resting State EEG
Lumbar Puncture
Lumbar Puncture
MRI
60 Minutes MRI
Interventions
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Blood Sample
Blood Sample
Neurocognitive Assessment
Neurocognitive Assessment
Resting State EEG
10-20 Minutes of Resting State EEG
Lumbar Puncture
Lumbar Puncture
MRI
60 Minutes MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent of the subject. or legal representative patient at the Anesthesiological-Operative Intensive Care Unit of the University Hospital Bonn, the Department of Anesthesiology, Intensive Care and Pain Therapy of the Malteser Hospital, or the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine of the Gemeinschaftskrankenhaus Bonn St. Petrus Hospital. At the Anesthesiological-Operative Intensive Care Unit of the University Hospital Bonn, only, or 1) documentation of presumed will via a relative or legal representative . together with 2) Documentation of verification by a doctor independent of the study that the patient's study participation is unobjectionable. Written informed consent of patient will be obtained at the earliest time possible.
* Aged 25-80 years
* Male or female
* Admitted to the intensive care units of the Anesthesiological-Operative Intensive Care Unit of the University Hospital Bonn, from the Department of Anesthesiology, Intensive Care and Pain Therapy of the Malteser Hospital or from the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine of the Gemeinschaftskrankenhaus Bonn St. Petrus Hospital.
* Duration of ICU stay must be a minimum of 24 hours. In case of transfer to intermediate care or the observation ward before the 24 hour ICU period is complete, study parameters must be allowed to be assessed.
* Fulfill the criteria of sepsis and/or septic shock patients according to theThird International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3, Singer et al, 2016).
Postoperative ICU Patients will only be included in the study if they meet all of the following criteria:
* Written informed consent of the subject.
* Aged 25-80 years
* Male or female
* Admitted to the intensive care units of the Anesthesiological-Operative Intensive Care Unit of the University Hospital Bonn, which includes a surgical ICU, an anesthesiological ICU, and a cardio-surgical ICU
* Duration of ICU stay must be a minimum of 24 hours. In case of transfer to intermediate care or the observation ward before the 24 hour ICU period is complete, study parameters must be allowed to be assessed.
* Mini-Mental Status Examination (MMSE) Score of 25 or above
Healthy Controls will only be included in the study if they meet all of the following criteria:
* Written informed consent of the subject
* Aged 25-80 years
* Male or female
Exclusion Criteria
* Physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the study results, or may interfere with the subject's participation in this study
* Prior to the start of this study existence of preexisting severe diseases and/or conduction of surgery necessarily imply life expectancy less than 12 months
* Known or suspected persistent abuse of medication, drugs or alcohol now or in the past
* Known cerebral lesions, cerebral infarction or malignomas
* Dementia or history of other central nervous system diseases
* Cranial-cerebral injury
* Known HIV-Infection
* Known liver cirrhosis with a documented Child-Pugh Score of C prior to this study
* Liver transplants
* Prior to start of this study nursing care level of 2 or 3
* Prior to start of this study residing in a nursing home
* Fulfill the criteria of sepsis and/or septic shock patients according to theThird International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3, Singer et al, 2016).
* In the case that a postoperative ICU patient fulfills the criteria for sepsis during ICU stay, he/she will be moved to the sepsis group.
* Executing third-party cognitive and functional assessments of another patient-subject also included in this investigation
* History of ICU stay in the last 12 months
25 Years
80 Years
ALL
Yes
Sponsors
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University Hospital, Bonn
OTHER
German Center for Neurodegenerative Diseases (DZNE)
OTHER
Responsible Party
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Principal Investigators
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Michael T Heneka, M.D.
Role: PRINCIPAL_INVESTIGATOR
German Center for Neurodegenerative Diseases (DZNE)
Andreas Hoeft, M.D.
Role: STUDY_CHAIR
Department of Anesthesiology and Intensive Care Medicine, University Hospital Bonn
Christian Putensen, M.D.
Role: STUDY_CHAIR
Research Unit Pulmonary Dysfunction and Sepsis, Department of Anesthesiology and Intensive Care Medicine, University Hospital Bonn
Thomas Klockgether, M.D.
Role: STUDY_CHAIR
German Center for Neurodegenerative Diseases (DZNE)
Locations
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DZNE Center for Clinical Research
Bonn, North Rhine-Westphalia, Germany
Department of Anesthesiology, University Hospital Bonn
Bonn, North Rhine-Westphalia (nrw), Germany
Countries
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Central Contacts
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References
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Weberpals M, Hermes M, Hermann S, Kummer MP, Terwel D, Semmler A, Berger M, Schafers M, Heneka MT. NOS2 gene deficiency protects from sepsis-induced long-term cognitive deficits. J Neurosci. 2009 Nov 11;29(45):14177-84. doi: 10.1523/JNEUROSCI.3238-09.2009.
Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
Semmler A, Widmann CN, Okulla T, Urbach H, Kaiser M, Widman G, Mormann F, Weide J, Fliessbach K, Hoeft A, Jessen F, Putensen C, Heneka MT. Persistent cognitive impairment, hippocampal atrophy and EEG changes in sepsis survivors. J Neurol Neurosurg Psychiatry. 2013 Jan;84(1):62-9. doi: 10.1136/jnnp-2012-302883. Epub 2012 Nov 7.
Sonneville R, Verdonk F, Rauturier C, Klein IF, Wolff M, Annane D, Chretien F, Sharshar T. Understanding brain dysfunction in sepsis. Ann Intensive Care. 2013 May 29;3(1):15. doi: 10.1186/2110-5820-3-15.
Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.
Widmann CN, Heneka MT. Long-term cerebral consequences of sepsis. Lancet Neurol. 2014 Jun;13(6):630-6. doi: 10.1016/S1474-4422(14)70017-1.
Widmann CN, Schewe JC, Heneka MT. Sepsis-associated encephalopathy versus sepsis-induced encephalopathy--authors' reply. Lancet Neurol. 2014 Oct;13(10):968-9. doi: 10.1016/S1474-4422(14)70204-2. No abstract available.
Lindlau A, Widmann CN, Putensen C, Jessen F, Semmler A, Heneka MT. Predictors of hippocampal atrophy in critically ill patients. Eur J Neurol. 2015 Feb;22(2):410-5. doi: 10.1111/ene.12443. Epub 2014 Apr 12.
Related Links
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German Center for Neurodegenerative Disease (DZNE)
Department of Anesthesiology, University Hospital Bonn
Other Identifiers
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2011-003014-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BN005
Identifier Type: -
Identifier Source: org_study_id
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