Biochemical Predictors of Delirium in Cardiac Surgery

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03931499
• Other study ID #: DEL2019
• Status: Recruiting
• Start date: June 10, 2019
• Est. completion date: January 2021

Study information

• Verified date: May 2020
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Vladimir Lomivorotov, MD, PhD
• Phone: 83833476058
• Email: v.lomivorotov[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	E. Meshalkin National Medical Research Center	Novosibirsk

Sponsors (2)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation	Novosibirsk State University

Country where clinical trial is conducted

Russian Federation, 

Outcome

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