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Quetiapine as Prophylaxis for Delirium in CABG

Primary Purpose

Delirium

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Quetiapine
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 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 Exclusion Criteria: .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) 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

Sites / Locations

  • Ain shams university hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group Q

Group C

Arm Description

will receive 25 mg quetiapine at night of surgery and 25 mg daily for 7 days postoperative

will receive placebo alone

Outcomes

Primary Outcome Measures

delirium incidence
CAM_ICU

Secondary Outcome Measures

days without delirium
days
duration of delirium if it appear
days
severity of delirium
DRS-R-89
length of stay in the ICU
days
the length of stay in the hospital
days
the ICU mortality
number

Full Information

First Posted
February 22, 2023
Last Updated
April 5, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05801289
Brief Title
Quetiapine as Prophylaxis for Delirium in CABG
Official Title
Quetiapine as a Prophylactic Agent for Early Postoperative Delirium in High Risk Patients in Open Heart Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Q
Arm Type
Active Comparator
Arm Description
will receive 25 mg quetiapine at night of surgery and 25 mg daily for 7 days postoperative
Arm Title
Group C
Arm Type
No Intervention
Arm Description
will receive placebo alone
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
Seroquel
Intervention Description
Giving the drug to group Q
Primary Outcome Measure Information:
Title
delirium incidence
Description
CAM_ICU
Time Frame
3 days postoperative
Secondary Outcome Measure Information:
Title
days without delirium
Description
days
Time Frame
5 days postoperative
Title
duration of delirium if it appear
Description
days
Time Frame
7 days postoperative
Title
severity of delirium
Description
DRS-R-89
Time Frame
7 days postoperative
Title
length of stay in the ICU
Description
days
Time Frame
3 days postoperative
Title
the length of stay in the hospital
Description
days
Time Frame
7 days postoperative
Title
the ICU mortality
Description
number
Time Frame
3 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: .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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wael abdelmoneim, MD
Phone
01224576517
Ext
202
Email
waelelswefi@med.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
MOHAMED S SHORBAGY, MD
Phone
01227528857
Ext
202
Email
dr.mohammedelshorbagy@gmail.com
Facility Information:
Facility Name
Ain shams university hospitals
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama Ibrahim Mansour, MD
Phone
26857539
Ext
202
Email
Vice.research@med.asu.edu.eg

12. IPD Sharing Statement

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Quetiapine as Prophylaxis for Delirium in CABG

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