Biochemical Predictors of Delirium in Cardiac Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Delirium
• Intervention / Treatment: Diagnostic test: Metabolomic analysis

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Vladimir Lomivorotov, MD, PhD; Phone Number: 83833476058; Email: v.lomivorotov@gmail.com
• Study Contact Backup: Name: Gleb Moroz; Email: glebmorozz@gmail.com

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Recruiting
    • E. Meshalkin National Medical Research Center
    • Contact: Vladimir Lomivorotov; Phone Number: 89139164103

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient undergoing cardiac surgery under cardiopulmonary bypass

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Collaborators: Novosibirsk State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 10, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (ACTUAL): April 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: DEL2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No