DeliriumNCT02084394
Cerebral Blood Flow During CPB During Cardiac Surgery and the Presence of Post op Delirium
An observational study of Delirium, run by Johns Hopkins University at 1 site in United States.
Trial summary
Cardiac surgery is associated with multiple events and issues that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. The risk for postoperative delirium is generally thought to result from some previous health factors added to the susceptibility of the cardiac… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Delirium
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 2016
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are under going cardiac bypass surgery with the use of cardiac perfusion
Who may be able to join
- Patients in the study will be 50 or older undergoing elective cardiovascular surgery using cardiopulmonary bypass.
- Patients who can speak, read and understand the English language.
- Patients who understand the nature of the study and are willing to sign the consent form
Who cannot join
- Emergency surgery or patients intubated before surgery and, thus, cannot give informed consent.
- Patients diagnosed with neurocognitive disorders (e.g. Alzheimer's, Dementia)
- MMSE score greater than 21 Patients taking antipsychotic drugs A history of drug abuse
- Patients with an implant in the brain underneath the CerOx probes
- Women who are pregnant.
- History of significant, prohibitive skin allergies or reactions-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non Invasive Monitoring of Cerebral Blood Flow During and After Cardiopulmonary Bypass to Assess and Compare for the Presence of Delirium in Post Operative Patients (DELIRIUM)
Cardiac surgery is associated with multiple events and issues that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. The risk for postoperative delirium is generally thought to result from some previous health factors added to the susceptibility of the cardiac surgery process.
Read the detailed description
Cardiac surgery is associated with multiple perturbations that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. These same perturbations likely also increase the risk for postoperative delirium although there are little data that have evaluated this hypothesis.
As the subject is prepared for surgery 2 contact probes will be placed on the forehead to monitor the rSO2 and cerebral blood flow. This monitor can also measureblood flow velocity in blood vessels in the forehead.
This will only be done while the subject is on the cardiac bypass machine during the surgery and end shortly after entering the intensive care unit.Prior to surgery and then once a day on three of the first four postoperative days, patients will be assessed for the presence and severity of delirium with brief standard psychological exams. We will compare rSO2 and CBF changes between patients with and without delirium
- Conditions
- Delirium
- Keywords
- CBF autoregulation, rSO2,doppler, TCD, delirium,
- Medical subject headings
- Delirium, Choroideremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| no intervention | Contact with enrolled subjects requires application of ceberal oximetry electrodes and the concommittent ultrasound of the temporal artery. Deemed interventional by JHUIRB but no actual intervention done to subject. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium
To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium.
Measured: 3 days post op
Secondary outcomes (1)
recovery pattern of rSO2
To evaluate the recovery pattern of rSO2 and CBF for up to 6 hrs after CPB for ICU patients who experience delirium within three days after cardiac surgery compared with patients without delirium.
Measured: 3 post op days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionOct 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Ornim Medical
- Responsible party
- Principal investigator, Dr Kaushik Mandal, Johns Hopkins University
- Investigators
- Kaushik Mandal, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084394
- Sponsor's protocol ID
- NA_0007115
- Status last verified
- Feb 2016
- First submitted
- 25 Feb 2014
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Monitoring of Cerebral Blood Flow During and After Cardiopulmonary Bypass to Assess and Compare for the Presence of Delirium in Post Operative Patients (DELIRIUM)
- ClinicalTrials.gov ID
- NCT02084394
- Acronym / sponsor ID
- NA_0007115
- Conditions
- Delirium
- Keywords
- CBF autoregulation, rSO2,doppler, TCD, delirium,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Ornim Medical
- Study start
- Jun 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 12 Mar 2014 (estimated)
- 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.
Cardiac surgery is associated with multiple events and issues that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. The risk for postoperative delirium is generally thought to result from some previous health factors added to the susceptibility of the cardiac surgery process.
Detailed description
Cardiac surgery is associated with multiple perturbations that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. These same perturbations likely also increase the risk for postoperative delirium although there are little data that have evaluated this hypothesis.
As the subject is prepared for surgery 2 contact probes will be placed on the forehead to monitor the rSO2 and cerebral blood flow. This monitor can also measureblood flow velocity in blood vessels in the forehead.
This will only be done while the subject is on the cardiac bypass machine during the surgery and end shortly after entering the intensive care unit.Prior to surgery and then once a day on three of the first four postoperative days, patients will be assessed for the presence and severity of delirium with brief standard psychological exams. We will compare rSO2 and CBF changes between patients with and without delirium
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no intervention | – | –Contact with enrolled subjects requires application of ceberal oximetry electrodes and the concommittent ultrasound of the temporal artery. Deemed interventional by JHUIRB but no actual intervention done to subject. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are under going cardiac bypass surgery with the use of cardiac perfusion
Key inclusion criteria (3 listed)
- Patients in the study will be 50 or older undergoing elective cardiovascular surgery using cardiopulmonary bypass.
- Patients who can speak, read and understand the English language.
- Patients who understand the nature of the study and are willing to sign the consent form
Key exclusion criteria (6 listed)
- Emergency surgery or patients intubated before surgery and, thus, cannot give informed consent.
- Patients diagnosed with neurocognitive disorders (e.g. Alzheimer's, Dementia)
- MMSE score greater than 21 Patients taking antipsychotic drugs A history of drug abuse
- Patients with an implant in the brain underneath the CerOx probes
- Women who are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium
Time frame: 3 days post op
To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium.
1 secondary outcome
recovery pattern of rSO2
Time frame: 3 post op days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Kaushik Mandal, MD principal investigator
Johns Hopkins University
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 Delirium, run by Johns Hopkins University at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 9 Feb 2016. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium (time frame: 3 days post op). 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 9 Feb 2016.