Perioperative Risk Factors for Intensive Care Delirium After Cardiac Surgery

Delirium Clinical Trial

Official title:

Incidence and Perioperative Risk Factors for Early Intensive Care Delirium Following Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743689
• Other study ID #: DELI-1
• Status: Completed
• Phase: N/A
• First received: April 13, 2016
• Last updated: October 30, 2016
• Start date: March 2015

Study information

• Verified date: October 2016
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

A consecutive series of patients scheduled for elective cardiac surgery is included in the study. Delirium screening is performed using Intensive Care Delirium Screening Checklist. Preoperative cognitive state is evaluated with Mini-Mental State Examination. Information of possible risk factors is collected from patient's history and chart. The Snoring, Tiredness, Observed apnea, high blood Pressure-Body mass index (BMI), Age, Neck circumference and Gender questionnaire (STOP-BANG questionnaire) is used for obstructive sleep apnea screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
Lithuania	Vilnius University Hospital Santariskiu Clinics	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

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