Delirium Clinical Trial
Official title:
Incidence and Perioperative Risk Factors for Early Intensive Care Delirium Following Cardiac Surgery
NCT number | NCT02743689 |
Other study ID # | DELI-1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | April 13, 2016 |
Last updated | October 30, 2016 |
Start date | March 2015 |
Verified date | October 2016 |
Source | Vilnius University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Lithuania: Bioethics Committee |
Study type | Observational |
The aim of the study is to identify the incidence of early postoperative delirium in intensive care patients after cardiac surgery and detect possible risk factors associated with increased risk for developing delirium after cardiac surgery.
Status | Completed |
Enrollment | 191 |
Est. completion date | |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - elective cardiac surgery - patient spends more than 1 day in the intensive care unit after the surgery Exclusion Criteria: - refusal to participating in the study - documented severe central nervous system, cognitive or psychiatric disorder - unable to be screened with Intensive Care Delirium Screening Checklist up to 6th postoperative day (e.g. deeply sedated, intubated patients) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Lithuania | Vilnius University Hospital Santariskiu Clinics | Vilnius |
Lead Sponsor | Collaborator |
---|---|
Vilnius University |
Lithuania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of early postoperative delirium in intensive care patients after cardiac surgery | Within 5 days after the surgery | No | |
Secondary | Perioperative risk factors for delirium after cardiac surgery | Preoperative risk factors include demographic data, comorbidities and standard preoperative laboratory and instrumental testing results as well as preoperative cognitive status evaluation, performed a day before the surgery. If the patient does not develop delirium, information on intraoperative and postoperative risk factors is collected up to discharge from intensive care unit or maximum 5 postoperative days, whichever happens earlier. If delirium occurs, data on risk factors is collected up to the beginning of delirium. | Up to 5 postoperative days or occurence of delirium if it develops earlier | No |
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