Delirium Clinical Trial
Official title:
Risk Factors for Delirium Following Cardiac Surgery
Verified date | February 2017 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will evaluate several potential risk factors for postoperative delirium in cardiac surgery patients. The risk factors will include use of specific preoperative, intraoperative, and/or postoperative medications. Other risk factors investigated may include exposure to cardiopulmonary bypass, surgical technique, and or duration of surgery.
Status | Completed |
Enrollment | 5600 |
Est. completion date | November 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Patients undergoing elective cardiac surgery (coronary artery bypass grafting (CABG), CABG+valve(s), valve only) *depending on the study - OR aortic valve replacement (will include patients undergoing transcatheter aortic valve replacement (TAVR) and patients undergoing only aortic valve replacement with CPB) Exclusion Criteria: Emergency cases will be excluded. *depending on the study - Patients undergoing any valve replacement surgery other than aortic valve |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of delirium | CAM-ICU positive at any time after cardiac surgery | During ICU stay, average may be 4 days | |
Secondary | Duration of delirium | Duration of delirium in days with CAM-ICU positive | During ICU stay, average may be 4 days | |
Secondary | In hospital and 30 day mortality | Mortality during hospital admission and within 30 days of surgery | During hospital admission and within 30 days of surgery | |
Secondary | Acute kidney injury | Kidney injury defined using KDIGO AKI staging criteria | During hospital stay, average may be 1 week | |
Secondary | Atrial fibrillation | Atrial fibrillation defined as documentation of atrial fibrillation by bedside nurse in nursing flowsheet | During hospital stay, average may be 1 week | |
Secondary | Total length of stay | Total length of stay defined as difference between admission and discharge dates | During hospital stay, average may be 1 week | |
Secondary | Days in ICU | Days in ICU defined as total days in ICU before floor transfer | During ICU stay, average may be 4 days |
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