Perioperative Risk Factors for Intensive Care Delirium After Cardiac Surgery

Completed

• Conditions: Delirium

• Registration Number: NCT02743689
• Lead Sponsor: Vilnius University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-19
• Primary Completion: 2016-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-30
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of early postoperative delirium in intensive care patients after cardiac surgery	Within 5 days after the surgery

Secondary Outcome Measures

Name	Time	Method
Perioperative risk factors for delirium after cardiac surgery	Up to 5 postoperative days or occurence of delirium if it develops earlier	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.

Trial Locations

Locations (1)

Vilnius University Hospital Santariskiu Clinics; 🇱🇹 Vilnius, Lithuania