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Biochemical Predictors of Delirium in Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931499
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
Novosibirsk State University
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

Brief Summary:
Delirium is a common neurologic complication after cardiac surgery occuring in 30-50% of patients. The occurence of this complication is associated with worse outcomes, including prolonged length of stay in the ICU and hospital, increased morbidity and mortality. Considering great clinical significance of this complication, the search for early predictors of postoperative delirium remains an urgent task. The purpose of this prospective observational study is to test the hypothesis that metabolomic changes before and after cardiac surgery could be served as early predictors of this complication.

Condition or disease Intervention/treatment
Postoperative Delirium Diagnostic Test: Metabolomic analysis

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biochemical Predictors of Delirium in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study cohort
Patients undergoing surgery under cardiopulmonary bypass
Diagnostic Test: Metabolomic analysis
Blood will be collected in all patients blood before surgery and after surgery (postoperative day 1). Our study is based on a polar metabolomics profiling of plasma and/or serum using hybrid triple quadrupole mass spectrometer coupled with chromatographic system.




Primary Outcome Measures :
  1. Postoperative delirium [ Time Frame: 5 days after surgery ]
    Postoperative delirium will be diagnosed with CAM-ICU (confusion assessment method - intensive care unit)



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient undergoing cardiac surgery under cardiopulmonary bypass
Criteria

Inclusion Criteria:

  • surgery under cardiopulmonary bypass
  • Age > 60 years
  • CABG surgery or valve surgery (repair/replacement)

Exclusion Criteria:

  • urgent surgery
  • surgery on aorta
  • combined procedures (CABG+valves)
  • significant stenosis of carotid arteries
  • Parkinson's disease
  • liver cirrhosis
  • use of anticholinergic drugs, antidepressants, antiepileptic or chemotherapy drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931499


Contacts
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Contact: Vladimir Lomivorotov, MD, PhD 83833476058 v.lomivorotov@gmail.com
Contact: Gleb Moroz glebmorozz@gmail.com

Locations
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Russian Federation
E. Meshalkin National Medical Research Center Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Vladimir Lomivorotov    89139164103      
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Novosibirsk State University
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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT03931499    
Other Study ID Numbers: DEL2019
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders