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OpenTrials
Completed

NCT Number: NCT02743689

Perioperative Risk Factors for Intensive Care Delirium After Cardiac Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vilnius University Hospital Santariskiu Clinics

Vilnius, 08661, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Incidence of early postoperative delirium in intensive care patients after cardiac surgery

    Time frame: Within 5 days after the surgery

Secondary outcomes

  1. Perioperative risk factors for delirium after cardiac surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
First posted
Apr 19, 2016
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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