Biochemical Predictors of Delirium in Cardiac Surgery | NCT03931499

Studies
Biochemical Predictors of Delirium in Cardiac Surgery

NCT03931499

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Status

Unknown status

Last Update Posted

May 19, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Postoperative Delirium

Interventions

Metabolomic analysis

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2019Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Jan 2021Estimated

First Submitted Date

Apr 26, 2019

First Submission Date that Met QC Criteria

Apr 26, 2019

First Posted Date

Apr 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2020

Last Update Posted Date

May 19, 2020Actual

Name	Class
Novosibirsk State University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study cohort		Patients undergoing surgery under cardiopulmonary bypass	Diagnostic Test: Metabolomic analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metabolomic analysis	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative delirium	Postoperative delirium will be diagnosed with CAM-ICU (confusion assessment method - intensive care unit)	5 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patient undergoing cardiac surgery under cardiopulmonary bypass

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vladimir Lomivorotov, MD, PhD	Contact	83833476058		v.lomivorotov@gmail.com
Gleb Moroz	Contact			glebmorozz@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
E. Meshalkin National Medical Research Center	Recruiting	Novosibirsk		630055	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium

Ancestor Terms

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

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Browse Branches

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