DeliriumNCT03246165
Predictive Factors and Complications of Delirium
An observational study of Delirium and Surgery--Complications, run by University of Sao Paulo.
Trial summary
The objective of this research was to determine the incidence, predisposing and triggering factors of delirium following cardiac surgery and its consequences within 30 days of surgery and during a 12-18-month follow-up in older adult patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium, Surgery--Complications, Age Problem
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2011to 30 Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients submitted to perioperative evaluation for elective cardiac surgery at the hospital de Messejana in Fortaleza, Ceara.
Who may be able to join
- Elective cardiovascular surgery
Who cannot join
- Blindness,
- deafness,
- previous stroke
- dementia
- delirium at inclusion, preoperatively
- creatinine clearance < 30 ml/min
- emergency surgery
About this study
Official title: Incidence, Predictive Factors and Complications of Delirium in Postoperative Cardiac Surgery Elderly Patients
The objective of this research was to determine the incidence, predisposing and triggering factors of delirium following cardiac surgery and its consequences within 30 days of surgery and during a 12-18-month follow-up in older adult patients.
Read the detailed description
Delirium is a transient and fluctuating course syndrome of acute onset that is characterized by reduced level of consciousness, global cognitive dysfunction, and disorder in the sleep-wake cycle. In patients undergoing cardiac surgery, delirium is a complication that affects 2-57% of the patients, reaching as high as 73% in older subjects.
The identification of patients at high risk for delirium is important to deliver proper care and avoid the consequences of this complication. However, previous studies published on the subject have not delivered definitive results in the cardiac surgery setting. Low educational level has also been studied as a risk factor for delirium after surgery but never in a group of cardiac surgery patients that includes a significant rate of illiteracy.
The objective of this research was to determine the incidence, predisposing and triggering factors of delirium following cardiac surgery and its consequences within 30 days of surgery and during a 12-18-month follow-up in older adult patients.
- Conditions
- Delirium, Surgery--Complications, Age Problem
- Being tested
- Cardiac surgery
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
Coronary bypass, heart valve replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Delirium was assessed using the Confusion Assessment Method for the Intensive Care Unit
Measured: Until hospital discharge or 30 days after surgery, and for up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start1 Sep 2011
- Primary completion30 Dec 2013
- Study completion30 Jun 2015
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 University of Sao PauloThe 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
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Messejana
- Responsible party
- Principal investigator, Bruno Caramelli, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246165
- Sponsor's protocol ID
- 825/11
- Status last verified
- Mar 2019
- First submitted
- 7 Aug 2017
- Last updated
- 26 Mar 2019
- 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 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Predictive Factors and Complications of Delirium in Postoperative Cardiac Surgery Elderly Patients
- ClinicalTrials.gov ID
- NCT03246165
- Acronym / sponsor ID
- 825/11
- Conditions
- Delirium, Surgery--Complications, Age Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Hospital de Messejana
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 30 Dec 2013 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 11 Aug 2017 (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.
The objective of this research was to determine the incidence, predisposing and triggering factors of delirium following cardiac surgery and its consequences within 30 days of surgery and during a 12-18-month follow-up in older adult patients.
Detailed description
Delirium is a transient and fluctuating course syndrome of acute onset that is characterized by reduced level of consciousness, global cognitive dysfunction, and disorder in the sleep-wake cycle. In patients undergoing cardiac surgery, delirium is a complication that affects 2-57% of the patients, reaching as high as 73% in older subjects.
The identification of patients at high risk for delirium is important to deliver proper care and avoid the consequences of this complication. However, previous studies published on the subject have not delivered definitive results in the cardiac surgery setting. Low educational level has also been studied as a risk factor for delirium after surgery but never in a group of cardiac surgery patients that includes a significant rate of illiteracy.
The objective of this research was to determine the incidence, predisposing and triggering factors of delirium following cardiac surgery and its consequences within 30 days of surgery and during a 12-18-month follow-up in older adult patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients submitted to perioperative evaluation for elective cardiac surgery at the hospital de Messejana in Fortaleza, Ceara.
Key inclusion criteria (1 listed)
- Elective cardiovascular surgery
Key exclusion criteria (7 listed)
- Blindness,
- deafness,
- previous stroke
- dementia
- delirium at inclusion, preoperatively
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 |
|---|---|---|
| Cardiac surgeryCoronary bypass, heart valve replacement | Procedure or surgery | – |
Primary outcome
Delirium
Time frame: Until hospital discharge or 30 days after surgery, and for up to 18 months.
Delirium was assessed using the Confusion Assessment Method for the Intensive Care Unit
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 26 Mar 2019.
- Individual participant dataSharing planned: No
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
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Surgery--Complications, run by University of Sao Paulo.
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 1 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: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Delirium (time frame: Until hospital discharge or 30 days after surgery, and for up to 18 months.). 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 26 Mar 2019.