Long-term Outcomes of Critical Illness Survivors

• Conditions: Intensive Care Units

• Registration Number: NCT03940755
• Lead Sponsor: Jian-jun Yang

Brief Summary

The goal of this study is to assess the Long-term Outcomes of Critical Illness Survivors,including physical, psychological, and cognitive sequelae.

Detailed Description

An increasing number of patients survive critical illness; however, the evidence reveals that over the same period the number of patients being sent to rehabilitation settings have tripled . For those who do survive, the latest data indicate that 50-70% of ICU "survivors" will suffer cognitive impairment and 60-80% of "survivors" will suffer functional impairment or ICU-acquired weakness (ICU-AW).Still,there is a lack valid data on the long-term impact on morbidity from prospective observational studies. Therefore, the investigators designed an observational cohort which cover a broader range of outcomes to quantify long-term physical, psychological, and cognitive impairment after intensive care unit (ICU).Intensive Care Unit patients survive from critical illness will be approached for study recruitment and participation.Survival rate,Quality of life,Cognitive impairments,Depression and anxiety,PTSD,Physical activity,Neuromuscular impairment will be assessed 3 or 6 months after ICU discharge.

Study Timeline

• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-04
• Study First Posted: 2019-05-07
• Study Start: 2019-06-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-05
• Last Update Posted: 2020-01-07
• Primary Completion: 2020-10-01
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients aged >17 years
• Patients in intensive care unit(ICU) with at least one organ or system dysfunction,such as respiratory failure, cardiogenic shock,or septic shock.

Exclusion Criteria

• Refuse to participate
• Death before ICU discharge
• pre-existing cognitive impairment, malignant tumor

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival rate of ICU survivors	3 or 6 months after ICU discharge	Critically ill patients discharged from ICU are defined as survivors

Secondary Outcome Measures

Name	Time	Method
Assessment in depression and anxiety	3 or 6 months after ICU discharge	Depression and anxiety assessed with help of The Hospital Anxiety and Depression Scale(HADS).For Depression(D), 7 questions in total. Range of score for each question: 0-3. Total score summed: 0-21 ;For Anxiety(A): 7 questions in total. Range of score for each question: 0-3. Total score summed: 0-21 .For both D and A scales, higher scores represent worse outcome.
Assessment in PTSD	3 or 6 months after ICU discharge	Post-traumatic stress syndrome assessed with help of trauma screening questionnaire(TSQ).There are 10 questions in the TSQ. For each question, the answer is either YES or NO. More YES = worse outcome. At least 6 YES represents PTSD diagnosis.
Assessment in Physical dysfunction	3 or 6 months after ICU discharge	Functional disabilities assessed with help of Barthel index of ADL(activities of daily living).10 variables are addressed. Range of summed total score: 0-100. higher values represent better outcome.
Assessment of life quality	3 or 6 months after ICU discharge	Quality of Life assessed with help of The 36-item short from health survey(SF-36)questionnaire.The SF-36 has 8 scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability, higher scores = less disability.The 8 sections are listed below:PF：Physical Functioning,RP：Role-Physical,BP：Bodily Pain,GH:General Health,VT：Vitality,SF：Social Functioning,RE：Role-Emotional,MH：Mental Health.
Assessment in Cognitive impairments	3 or 6 months after ICU discharge	Cognitive impairments assessed with help of mini-mental state examination(MMSE).The MMSE has 5 scaled scores; the scores are weighted sums of the questions in each section. The 5 sections and their range of score are listed below:Orientation 0-10;Registration 0-3;Attention and calculation 0-5;Recall 0-3;Language 0-9.Total score range from 0-30. Lower scores = more disability, higher scores = less disability.
Neuromuscular impairment	3 or 6 months after ICU discharge	Neuromuscular impairment will be assessed by electromyography/nerve conduction study
Patients' care and support needs;social and economical consequences	3 or 6 months after ICU discharge	Patients' information of specific needs and supports and social or economical impact post ICU.

Trial Locations

Locations (2)

Jiangyin People's Hospital; 🇨🇳 Jiangyin, Jiangsu, China

Zhongda Hospital; 🇨🇳 Nanjing, Jiangsu, China