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Clinical Trials/NCT03931499
NCT03931499
Unknown
Not Applicable

Biochemical Predictors of Delirium in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country100 target enrollmentJune 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Delirium
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Enrollment
100
Locations
1
Primary Endpoint
Postoperative delirium
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2019
End Date
January 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Meshalkin Research Institute of Pathology of Circulation
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Postoperative delirium

Time Frame: 5 days after surgery

Postoperative delirium will be diagnosed with CAM-ICU (confusion assessment method - intensive care unit)

Study Sites (1)

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