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NCT03806413 Clinical Trial

Post-surgical Delirium in Patients Undergoing Open Heart Surgery.

Delirium Clinical Trial

Official title:
Post-surgical Delirium in Patients Undergoing Open Heart Surgery.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03806413
Other study ID # 16/68(8/2/2017)
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2024
Est. completion date December 31, 2024

Study information
Verified date December 2023
Source University of Alexandria
Contact Mohammad Hazem Ahmad Sabry, MB,ChB
Phone 01062718827
Email mohammad_hazem@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Post-surgical delirium in patients undergoing open heart surgery. Introduction Delirium occurs after open heart surgery may reach about 1/3 of the patients.(1) Aim The aim of this study is to determine the incidence of delirium after open heart surgery and the associated risk factors in Alexandria University hospital. Patients and Methods The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery.

Description:

Post-surgical delirium in patients undergoing open heart surgery. Introduction Delirium occurs after open heart surgery may reach about 1/3 of the patients.(1) Aim The aim of this study is to determine the incidence of delirium after open heart surgery and the associated risk factors in Alexandria University hospital. Patients and Methods The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery. Results Results will be collected in tables and graphs. Appropriate statistical analysis will be done. Discussion Results of the study will be discussed compared to other studies. References 1-Jannati Y, Bagheri-Nesami M, Sohrabi M, Yazdani-Cherati J, Mazdarani S. Factors associated with post-surgical delirium in patients undergoing open heart surgery. Oman Med J. 2014 Sep;29(5):340-5.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:Adult patients undergoing open heart surgery. - Exclusion Criteria: Children, patient refusal. -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Open heart surgery
The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery.

Locations
Country Name City State
Egypt Alexandria Faculty of Medicine Alexandria

Sponsors (1)
Lead Sponsor Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Jannati Y, Bagheri-Nesami M, Sohrabi M, Yazdani-Cherati J, Mazdarani S. Factors associated with post-surgical delirium in patients undergoing open heart surgery. Oman Med J. 2014 Sep;29(5):340-5. doi: 10.5001/omj.2014.91. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Post-surgical delirium in patients undergoing open heart surgery. Post-surgical delirium in patients undergoing open heart surgery. 1 year
Secondary Mortality Mortality 1 year
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