Postoperative DeliriumNCT03931499
Biochemical Predictors of Delirium in Cardiac Surgery
An observational study of Postoperative Delirium, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Metabolomic analysis
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jun 2019to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing cardiac surgery under cardiopulmonary bypass
Who may be able to join
- surgery under cardiopulmonary bypass
- Age > 60 years
- CABG surgery or valve surgery (repair/replacement)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Gleb Moroz contact
Russia1 site, 1 recruiting
- Recruiting
E. Meshalkin National Medical Research Center
Novosibirsk, 630055
Vladimir Lomivorotov, 89139164103
About this study
Official title: 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.
- Conditions
- Postoperative Delirium
- Being tested
- Metabolomic analysis
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolomic analysisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Patients undergoing surgery under cardiopulmonary bypass Receives: Diagnostic Test: Metabolomic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
Postoperative delirium will be diagnosed with CAM-ICU (confusion assessment method - intensive care unit)
Measured: 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start10 Jun 2019
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Collaborators
- Novosibirsk State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931499
- Sponsor's protocol ID
- DEL2019
- Status last verified
- May 2020
- First submitted
- 26 Apr 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Predictors of Delirium in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT03931499
- Acronym / sponsor ID
- DEL2019
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Collaborators
- Novosibirsk State University
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Diagnostic Test: Metabolomic analysisPatients undergoing surgery under cardiopulmonary bypass |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing cardiac surgery under cardiopulmonary bypass
Key inclusion criteria (3 listed)
- surgery under cardiopulmonary bypass
- Age > 60 years
- CABG surgery or valve surgery (repair/replacement)
Key exclusion criteria (7 listed)
- urgent surgery
- surgery on aorta
- combined procedures (CABG+valves)
- significant stenosis of carotid arteries
- Parkinson's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolomic analysisBlood 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. | Diagnostic test | Study cohort |
Primary outcome
Postoperative delirium
Time frame: 5 days after surgery
Postoperative delirium will be diagnosed with CAM-ICU (confusion assessment method - intensive care unit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: No
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The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
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Prediction and Prevention of Postoperative Mortality and Morbidity
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gleb Moroz contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Lomivorotov, MD, PhD (83833476058, v.lomivorotov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: 5 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.