Prevalence of the post-intensive care syndrome in a Dutch suburban cohort and a patients perspective on prevention and treatment interventions

• Conditions: Combinatie van cogitieve, psychische en fysieke facoren. Tezamen met effecten op sociale factor en werk-inkomen; intensive care related complications; Post intensive care syndrome

• Registration Number: NL-OMON42477
• Lead Sponsor: Sint Franciscus Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Patients between 18-65 years of age. Patients > 65 were not included because of 2 reasons: The survey has a low response rate in the >65 population, and because we wanted to determine the impact on employment and economic impact.
- Patients admitted for the first time to the ICU during their hospital stay with an ICU length of stay >= 48 h and fulfilling the following criteria:
- Severe sepsis and septic shock was defined according to previously published criteria6.
- Patients who received a tracheotomy during their ICU stay
- Patients who were diagnosed with ARDS during their hospital stay
- Patients with prolonged mechanical ventilation (> 7 days)

Exclusion Criteria

- Patients younger than 18 years
- who were pregnant
- known participation in another randomized controlled biomedical study
- elective postoperative admission, uncomplicated during ICU admission

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To explore the long-term prevalence of PICS in a representative sample of Dutch<br /><br>adult survivors after intensive care treatment<br /><br>Questionaire consists of:<br /><br>- Health related quality of life using the Short Form 36 Version 2 (SF-36)<br /><br>questionnaire<br /><br>- Health related quality of life using the EQ5-D questionnaire<br /><br>- Physical impairments/rehabilitation using the SF-36 questionnaire<br /><br>- Prevalence of post-traumatic stress using the Impact of Event Scale (IES)<br /><br>questionnaire<br /><br>- A novel question set designed to determine changes in family circumstances,<br /><br>socio-economic stability and care requirements.<br /><br>- Novel questions regarding the prevalence of a intervention.<br /><br><br /><br>For the complete questionnaire, see the attachment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Treatment related information<br /><br>- Age<br /><br>- Sex<br /><br>- BMI<br /><br>- Race<br /><br>- ICU stay (days)<br /><br>- APACHE II / APACHE IV / SOFA score.<br /><br>- scoring of delirium<br /><br>- days of mechanical ventilation (endotracheal vs tracheotomy)<br /><br>- noninvasive ventilation<br /><br>- use of vasopressors<br /><br>- use of (analgo)-sedatives (remifentanil/ propofol etc)<br /><br>- use of analgetics (morfine / paracetamol / sufentanyl / fentanyl)<br /><br>- use of Haldol / Is delirium present during ICU stay<br /><br>- RASS score (if applicable)</p><br>