DeliriumNCT05801289
Quetiapine as Prophylaxis for Delirium in CABG
A study testing Quetiapine in people with Delirium, run by Ain Shams University at 1 site in Egypt.
Trial summary
low-dose quetiapine may be effective in preventing delirium in patients. The purpose of this study is to evaluate the efficacy and safety of quetiapine for delirium prophylaxis in cabg Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- Quetiapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Dec 2022to Apr 2023
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients aged 65 or older old of age undergoing open heart surgery and having an equal or greater score of 5 on the scale of Delphi.
- Age: 70-79 years: 1 point; ≥ 80 years: 2 points
- Physical activity: need for assistance, not self-sufficient: 2 points
- Alcoholism: 1 point
- Hearing impaired: 1 point
- History of delirium: 2 points
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- Emergency of surgery: 2 points
- No laparoscopic surgery: 2 points
- Admission critical unites: 3 points
- Value of C reactive protein (CRP) ≥ 10mg/dl: 1 point
Who cannot join
- .Patient refusal.
- Allergy to quetiapine
- Patients with a score less than 5 on Delphi scale
- Diagnosis of delirium on admission initial CAM-ICU (the Confusion Assessment Method-ICU) positive)
- Could not communicate due to previously diagnosed irreversible neurologic disease (stroke, cerebral hemorrhage, traumatic brain injury, dementia, etc.)
- High risk for ventricular arrhythmias (Corrected QT interval ≥ 460 millisecond in men, ≥ 470 millisecond in women or ongoing treatment with drugs known to prolong the QT interval (e.g., erythromycin, class Ia, Ic, III anti-arrhythmic drugs)
Show all 11Show fewer
- Second or third degree heart block
- High risk for drug interaction with quetiapine (phenytoin, carbamazepine, barbiturates)
- Electrolyte disturbance : Potassium less than 3 or magnesium less than 1.5
- Patient on antipsychotic drug treatment prior to admission
- Parkinson's disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university hospitals
Cairo, 11591
Osama Ibrahim Mansour, MD, 26857539 ext. 202, Vice.research@med.asu.edu.eg
About this study
Official title: Quetiapine as a Prophylactic Agent for Early Postoperative Delirium in High Risk Patients in Open Heart Surgeries
low-dose quetiapine may be effective in preventing delirium in patients. The purpose of this study is to evaluate the efficacy and safety of quetiapine for delirium prophylaxis in cabg
Read the detailed description
Group Q: will receive 25 mg quetiapine at night of surgery and 25 mg daily for 7 days postoperative (30 patients).
Group C: will receive placebo alone (30 patients). During the study period, enrolled patients will be assessed for delirium once daily (from 7:00 AM to 7:00 PM), and the assessment will be performed in two steps. First, level of sedation will be assessed using the RASS. If the patient will be deeply sedated or unarousable (RASS -4 or -5), the assessment will not be performed and the patient will be reassessed at a later time. If the patient has a RASS of -3to +4, then the assessment will be continued to the next step.
Second, delirium will be diagnosed using the CAM-ICU. The screening tool detects four features of delirium: acute onset of mental status change or a fluctuating course, inattention, disorganized thinking, and altered level of consciousness. To have delirium diagnosed, a patient displays the first two features with either the third or fourth feature.
The primary outcome is delirium incidence diagnosed with the CAM_ICU within the study period. If the CAM_ICU is positive at least once during the study period, it will be recorded that a delirium occurred.
Secondary outcomes is the rate of positive CAM-ICU (the number of positive CAM-ICU counts/the number of total CAM-ICU counts), days without delirium (number of days from the start of treatment until delirium), the duration of delirium if it appear (number of days with delirium), severity of delirium as measured with delirium rating scale revised 98 (DRS-R-89), the length of stay in the ICU, the length of stay in the hospital, the duration of intubation, a successful extubation, the ICU mortality, the overall mortality, measurement of QTc prolongation, and the use of rescue medication.
- Conditions
- Delirium
- Being tested
- Quetiapine
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Also called Seroquel
Giving the drug to group Q
| Study group | Role | What they receive |
|---|---|---|
| Group Q | Active comparator | will receive 25 mg quetiapine at night of surgery and 25 mg daily for 7 days postoperative Receives: Drug: Quetiapine |
| Group C | No intervention | will receive placebo alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
delirium incidence
CAM_ICU
Measured: 3 days postoperative
Secondary outcomes (6)
days without delirium
days
Measured: 5 days postoperative
duration of delirium if it appear
days
Measured: 7 days postoperative
severity of delirium
DRS-R-89
Measured: 7 days postoperative
length of stay in the ICU
days
Measured: 3 days postoperative
the length of stay in the hospital
days
Measured: 7 days postoperative
the ICU mortality
number
Measured: 3 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start4 Dec 2022
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
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 Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801289
- Sponsor's protocol ID
- R 293/2022
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quetiapine as a Prophylactic Agent for Early Postoperative Delirium in High Risk Patients in Open Heart Surgeries
- ClinicalTrials.gov ID
- NCT05801289
- Acronym / sponsor ID
- R 293/2022
- Conditions
- Delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 4 Dec 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 6 Apr 2023 (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.
low-dose quetiapine may be effective in preventing delirium in patients. The purpose of this study is to evaluate the efficacy and safety of quetiapine for delirium prophylaxis in cabg
Detailed description
Group Q: will receive 25 mg quetiapine at night of surgery and 25 mg daily for 7 days postoperative (30 patients).
Group C: will receive placebo alone (30 patients). During the study period, enrolled patients will be assessed for delirium once daily (from 7:00 AM to 7:00 PM), and the assessment will be performed in two steps. First, level of sedation will be assessed using the RASS. If the patient will be deeply sedated or unarousable (RASS -4 or -5), the assessment will not be performed and the patient will be reassessed at a later time. If the patient has a RASS of -3to +4, then the assessment will be continued to the next step.
Second, delirium will be diagnosed using the CAM-ICU. The screening tool detects four features of delirium: acute onset of mental status change or a fluctuating course, inattention, disorganized thinking, and altered level of consciousness. To have delirium diagnosed, a patient displays the first two features with either the third or fourth feature.
The primary outcome is delirium incidence diagnosed with the CAM_ICU within the study period. If the CAM_ICU is positive at least once during the study period, it will be recorded that a delirium occurred.
Secondary outcomes is the rate of positive CAM-ICU (the number of positive CAM-ICU counts/the number of total CAM-ICU counts), days without delirium (number of days from the start of treatment until delirium), the duration of delirium if it appear (number of days with delirium), severity of delirium as measured with delirium rating scale revised 98 (DRS-R-89), the length of stay in the ICU, the length of stay in the hospital, the duration of intubation, a successful extubation, the ICU mortality, the overall mortality, measurement of QTc prolongation, and the use of rescue medication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Q | Active comparator | Drug: Quetiapinewill receive 25 mg quetiapine at night of surgery and 25 mg daily for 7 days postoperative |
| Group C | No intervention | –will receive placebo alone |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Patients aged 65 or older old of age undergoing open heart surgery and having an equal or greater score of 5 on the scale of Delphi.
- Age: 70-79 years: 1 point; ≥ 80 years: 2 points
- Physical activity: need for assistance, not self-sufficient: 2 points
- Alcoholism: 1 point
- Hearing impaired: 1 point
Key exclusion criteria (11 listed)
- .Patient refusal.
- Allergy to quetiapine
- Patients with a score less than 5 on Delphi scale
- Diagnosis of delirium on admission initial CAM-ICU (the Confusion Assessment Method-ICU) positive)
- Could not communicate due to previously diagnosed irreversible neurologic disease (stroke, cerebral hemorrhage, traumatic brain injury, dementia, etc.)
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 |
|---|---|---|
| QuetiapineAlso: SeroquelGiving the drug to group Q | Drug | Group Q |
Primary outcome
delirium incidence
Time frame: 3 days postoperative
CAM_ICU
6 secondary outcomes
days without delirium
Time frame: 5 days postoperative
duration of delirium if it appear
Time frame: 7 days postoperative
severity of delirium
Time frame: 7 days postoperative
length of stay in the ICU
Time frame: 3 days postoperative
the length of stay in the hospital
Time frame: 7 days postoperative
the ICU mortality
Time frame: 3 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quetiapine in people with Delirium, run by Ain Shams University at 1 site in Egypt.
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 10 inclusion and 11 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 6 Apr 2023. 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 Egypt. 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 wael abdelmoneim, MD (01224576517 ext. 202, waelelswefi@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delirium incidence (time frame: 3 days postoperative). 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 6 Apr 2023.