Biochemical Predictors of Delirium in Cardiac Surgery
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2019
CompletedFirst Posted
Study publicly available on registry
April 30, 2019
CompletedStudy Start
First participant enrolled
June 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedMay 19, 2020
May 1, 2020
1.5 years
April 26, 2019
May 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative delirium
Postoperative delirium will be diagnosed with CAM-ICU (confusion assessment method - intensive care unit)
5 days after surgery
Study Arms (1)
Study cohort
Patients undergoing surgery under cardiopulmonary bypass
Interventions
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.
Eligibility Criteria
Patient undergoing cardiac surgery under cardiopulmonary bypass
You may qualify if:
- surgery under cardiopulmonary bypass
- Age \> 60 years
- CABG surgery or valve surgery (repair/replacement)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
E. Meshalkin National Medical Research Center
Novosibirsk, 630055, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2019
First Posted
April 30, 2019
Study Start
June 10, 2019
Primary Completion
December 1, 2020
Study Completion
January 1, 2021
Last Updated
May 19, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share