Biochemical Predictors of Delirium in Cardiac Surgery

NCT ID: NCT03931499

Last Updated: 2020-05-19

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-10

Study Completion Date

2021-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study cohort

Patients undergoing surgery under cardiopulmonary bypass

Metabolomic analysis

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novosibirsk State University

OTHER

Sponsor Role collaborator

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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E. Meshalkin National Medical Research Center

Novosibirsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Vladimir Lomivorotov, MD, PhD

Role: CONTACT

83833476058

Gleb Moroz

Role: CONTACT

Facility Contacts

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Vladimir Lomivorotov

Role: primary

89139164103

Other Identifiers

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DEL2019

Identifier Type: -

Identifier Source: org_study_id

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