Clinical trial NCT03806413: Post-surgical Delirium in Patients Undergoing Open Heart Surgery.
Official title: Post-surgical Delirium in Patients Undergoing Open Heart Surgery.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Delirium
Open Heart Surgery
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing open heart surgery.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:Adult patients undergoing open heart surgery. -

Exclusion Criteria: Children, patient refusal.

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Primary outcomes:
measure: Post-surgical delirium in patients undergoing open heart surgery.
timeFrame: 1 year
Secondary outcomes:
measure: Mortality
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Alexandria University
name: Mohammad Hazem I Ahmad Sabry, MB,ChB MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.